Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effects of rosiglitazone on the bone in postmenopausal women with type 2 diabetes mellitus
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Arm 1 Treatment A rosiglitazone up to 8mg/day |
Drug: Rosiglitazone
up to 8mg/day
|
Active Comparator: Arm 2 Treatment B metformin up to 2000mg/day |
Drug: Metformin
up to 2000mg/day
|
Outcome Measures
Primary Outcome Measures
- Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 [Baseline and Week 52]
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm.
- Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days [Baseline and Week 76+10 days]
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days [Week 52+10 days and Week 76+10 days]
FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
Secondary Outcome Measures
- Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 [Baseline and Week 52]
BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days [Week 52 + 10 days and Week 76 + 10 days]
BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days [Week 52 + 30 days and Week 76 + 30 days]
BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 [Week 52 and Week 76]
BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 [Week 52 and Week 76]
CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 [Week 52 and Week 76]
Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 [Week 52 and Week 76]
Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region.
- Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.
- Percent Change in Serum Estradiol From Week 52 to Week 76 [Week 52 and Week 76]
Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data.
- Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.
- Percent Change in Total Testosterone From Week 52 to Week 76 [Week 52 and Week 76]
Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data.
- Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
- Percent Change in Free Testosterone From Week 52 to Week 76 [Week 52 and Week 76]
Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
- Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 [Baseline, Week 52, and Week 76]
SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
- Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 [Week 52 and Week 76]
SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data.
Other Outcome Measures
- Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 [Week 52 and Week 76]
Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data.
- Percent Change in Free Estradiol From Week 52 to Week 76 [Week 52 and Week 76]
Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female, >55 to <80 years
-
5 years menopausal
-
Type 2 Diabetes Mellitus (T2DM) diagnosis according to American Diabetes Association (ADA), American Association of Clinical Endocrinologists (AACE), Canadian Diabetes Association (CDA), World Health Organization/International Diabetes Federation (WHO/IDF)
-
Drug-naïve (HbA1c < or = 9.0%); OR Prior monotherapy, submaximal doses of metformin (< or = 1000mg Metformin), sulfonylureas (< or = 5mg Glyburide, < or = 10mg Glipizide or < or = 8mg glimepiride) or full dose Januvia (100mg) (HbA1c < or = 8.5%); OR Prior monotherapy, > submaximal doses of metformin (>1000mg) or sulfonylureas (>5mg Glyburide, >10mg Glipizide or >8mg glimepiride) (HbA1c < or = 7.0%)
-
Weighs <300 lbs (136.4 kg)
-
Two or more vertebra (L1-L4) suitable for BMD measurement by dual x-ray absorptiometry (DXA)
-
Absolute BMD value consistent with T-score >-2.5 at femoral neck, lumbar spine and total hip
Exclusion Criteria:
-
Type 1 Diabetes Mellitus (T1DM) or history of diabetic ketoacidosis (DKA)
-
Renal or hepatic disease (clinically significant)
-
Hepatocellular reaction, severe edema, or medically serious fluid event associated with thiazolidinedione (TZD)
-
Recent (<6mos) history or clinical intervention for angina or myocardial infarction or is taking nitrates
-
Any stage of heart failure, i.e. New York Heart Association (NYHA) class I-IV
-
Systolic BP >160mmHg or diastolic BP >90mmHg while on antihypertensive
-
Hypersensitivity to TZDs, biguanides
-
Prior treatment with two or more oral anti-diabetic (OAD) agents
-
Bilateral hip replacements
-
Concurrent diseases affecting bone metabolism
-
Active malabsorption syndrome
-
Serum calcium outside the central lab reference range
-
Thyroid replacement therapy, serum thyroid stimulating hormone (TSH) must be within range
-
Vitamin D deficiency
-
Previous treatment with: strontium, intravenous (IV) bisphosphonate, fluoride, hormones, calcineurin inhibitors or methotrexate
-
Chronic systemic corticosteroid [e.g. glucocorticoid, mineralocorticoid] treatment of no more than two intra-articular injections within the past year or use of oral parenteral, or long-term, high-dose inhaled corticosteroids
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | GSK Investigational Site | Tucson | Arizona | United States | 85745 |
2 | GSK Investigational Site | Huntington Park | California | United States | 90255 |
3 | GSK Investigational Site | Los Angeles | California | United States | 90022 |
4 | GSK Investigational Site | Sacramento | California | United States | 95823 |
5 | GSK Investigational Site | San Diego | California | United States | 92117 |
6 | GSK Investigational Site | Torrance | California | United States | 90502 |
7 | GSK Investigational Site | Vista | California | United States | 92081 |
8 | GSK Investigational Site | Miami | Florida | United States | 33143 |
9 | GSK Investigational Site | Miami | Florida | United States | 33156 |
10 | GSK Investigational Site | Lexington | Kentucky | United States | 40504 |
11 | GSK Investigational Site | Slidell | Louisiana | United States | 70461 |
12 | GSK Investigational Site | Las Vegas | Nevada | United States | 89117 |
13 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87102 |
14 | GSK Investigational Site | Albuquerque | New Mexico | United States | 87106 |
15 | GSK Investigational Site | East Syracuse | New York | United States | 13057 |
16 | GSK Investigational Site | Kingston | New York | United States | 12401 |
17 | GSK Investigational Site | Columbia | South Carolina | United States | 29201 |
18 | GSK Investigational Site | Columbia | South Carolina | United States | 29204 |
19 | GSK Investigational Site | Kingsport | Tennessee | United States | 37660 |
20 | GSK Investigational Site | San Antonio | Texas | United States | 78221 |
21 | GSK Investigational Site | Wenatchee | Washington | United States | 98801 |
22 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | B1704ETD |
23 | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | C1012AAR |
24 | GSK Investigational Site | Buenos Aires | Argentina | 1425 | |
25 | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Argentina | C1128AAF | |
26 | GSK Investigational Site | Vancouver | British Columbia | Canada | V6H 3X8 |
27 | GSK Investigational Site | Brampton | Ontario | Canada | L6T 3T1 |
28 | GSK Investigational Site | Granby | Quebec | Canada | J2G 8Z9 |
29 | GSK Investigational Site | Tallinn | Estonia | 13415 | |
30 | GSK Investigational Site | Tallin | Estonia | 13419 | |
31 | GSK Investigational Site | Cuernavaca | Morelos | Mexico | 62250 |
32 | GSK Investigational Site | Monterrey | Nuevo León | Mexico | 64460 |
33 | GSK Investigational Site | Mérida | Yucatán | Mexico | 97129 |
34 | GSK Investigational Site | Durango | Mexico | 34000 | |
35 | GSK Investigational Site | Lahore | Pakistan | 54000 | |
36 | GSK Investigational Site | Manila | Philippines | 01008 | |
37 | GSK Investigational Site | Marikina City | Philippines | 1810 | |
38 | GSK Investigational Site | Alicante | Spain | 03114 | |
39 | GSK Investigational Site | Benidorm/Alicante | Spain | 03503 | |
40 | GSK Investigational Site | Granada | Spain | 18003 | |
41 | GSK Investigational Site | Granada | Spain | 18014 | |
42 | GSK Investigational Site | Petrer | Spain | 03610 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- AVD111179
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Period Title: 52-Week Double-Blind (DB) Period | ||
STARTED | 114 | 112 |
COMPLETED | 77 | 85 |
NOT COMPLETED | 37 | 27 |
Period Title: 52-Week Double-Blind (DB) Period | ||
STARTED | 76 | 84 |
COMPLETED | 69 | 80 |
NOT COMPLETED | 7 | 4 |
Baseline Characteristics
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period | Total |
---|---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Total of all reporting groups |
Overall Participants | 114 | 111 | 225 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
63.6
(6.61)
|
64.0
(6.46)
|
63.8
(6.52)
|
Sex: Female, Male (Count of Participants) | |||
Female |
114
100%
|
111
100%
|
225
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (participants) [Number] | |||
White - White/Caucasian/European |
82
71.9%
|
78
70.3%
|
160
71.1%
|
African American/African |
2
1.8%
|
8
7.2%
|
10
4.4%
|
American Indian or Alaskan Native |
6
5.3%
|
5
4.5%
|
11
4.9%
|
Asian - Central/South Asian |
13
11.4%
|
10
9%
|
23
10.2%
|
South East Asian |
4
3.5%
|
6
5.4%
|
10
4.4%
|
Mixed Race |
3
2.6%
|
2
1.8%
|
5
2.2%
|
East Asia |
4
3.5%
|
2
1.8%
|
6
2.7%
|
Outcome Measures
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 |
---|---|
Description | FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Change in FN BMD at Week 52 was only analyzed within the Rosiglitazone arm. |
Time Frame | Baseline and Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET are included in this primary analysis. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period |
---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 52 |
Mean (Standard Error) [percent change] |
-1.24
(0.619)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days |
---|---|
Description | FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Baseline at Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline and Week 76+10 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at baseline and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 65 | 70 |
Mean (Standard Error) [percent change] |
-1.91
(0.624)
|
0.31
(0.636)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days |
---|---|
Description | FN BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Bone mineral density is calculated as the mineral content of a bone divided by the area of the bone. DXA is the principal technique used for measuring BMD. Percent change from Week 52+10 days to Week 76+10 days was calculated as (BMD at Week 76+10 days minus BMD at Week 52+10 days)/BMD at Week 52+10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52+10 days and Week 76+10 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 56 | 62 |
Mean (Standard Error) [percent change] |
-0.07
(0.589)
|
-0.02
(0.585)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 |
---|---|
Description | BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 was calculated as (BMD at Week 52 minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline and Week 52 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at baseline and at Week 52 for the parameter of interest were analyzed. Only participants with Baseline DXA and Week 52 DXA measurements performed on or prior to initiating open-label MET were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 52 | 54 |
Femoral neck, n=52, 54 |
-1.24
(0.619)
|
0.72
(0.659)
|
Total hip, n=52, 54 |
-0.77
(0.417)
|
-0.38
(0.440)
|
Trochanter, n=52, 54 |
-0.21
(0.725)
|
-0.78
(0.768)
|
Lumbar spine, n=51, 53 |
-1.21
(0.473)
|
0.12
(0.505)
|
Title | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+10 Days to Week 76 + 10 Days |
---|---|
Description | BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 10 days toat Week 76 + 10 days was calculated as (BMD at Week 76 + 10 days minus BMD at Week 52 + 10 days)/BMD at Week 52 + 10 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 10 days and Week 76 + 10 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 performed up to 10 days after initiating OL MET and at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for the DXA lumbar spine measurement. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 56 | 62 |
Femoral neck, n=56, 62 |
-0.07
(0.589)
|
-0.02
(0.585)
|
Total hip, n=56, 62 |
0.40
(0.304)
|
-0.13
(0.301)
|
Trochanter, n=56, 62 |
-0.02
(0.475)
|
-0.68
(0.469)
|
Lumbar spine, n=55, 62 |
0.26
(0.440)
|
1.03
(0.442)
|
Title | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET and Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had correct positioning for all of the DXA measurements. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 65 | 73 |
Femoral neck, n=64, 73 |
-0.27
(0.559)
|
-0.25
(0.535)
|
Total hip, n=64, 73 |
0.00
(0.298)
|
-0.27
(0.283)
|
Trochanter, n=64, 73 |
-0.17
(0.495)
|
-0.47
(0.470)
|
Lumbar spine, n=65, 70 |
0.54
(0.445)
|
0.90
(0.442)
|
Title | Adjusted Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) at Week 52 and Week 76 |
---|---|
Description | BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone | Metformin |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 78 | 84 |
Week 52, GM - SE, BSAP, n=78, 84 |
-15.2
|
-29.7
|
Week 52, GM, BSAP, n=78, 84 |
-12.3
|
-27.3
|
Week 52, GM + SE, BSAP, n=78, 84 |
-9.3
|
-24.8
|
Week 76, GM - SE, BSAP, n=64, 77 |
-18.7
|
-26.7
|
Week 76, GM, BSAP, n=64, 77 |
-15.9
|
-24.3
|
Week 76, GM + SE, BSAP, n=64, 77 |
-12.9
|
-21.8
|
Week 52, GM - SE, P1NP, n=76, 83 |
5.0
|
-16.5
|
Week 52, GM, P1NP, n=76, 83 |
9.0
|
-13.3
|
Week 52, GM + SE, P1NP, n=76, 83 |
13.3
|
-9.9
|
Week 76 GM - SE, P1NP, n=63, 75 |
-11.2
|
-14.5
|
Week 76, GM, P1NP, n=63, 75 |
-6.9
|
-10.5
|
Week 76, GM + SE, P1NP, n=63, 75 |
-2.4
|
-6.4
|
Title | Adjusted Percent Change in Bone Specific Alkaline Phosphatase (BSAP) and Procollagen Type 1 N-propeptide (P1NP) From Week 52 to Week 76 |
---|---|
Description | BSAP and P1NP levels were measured in micrograms per liter (mcg/L) from blood samples. BSAP and P1NP are indicators of bone buildup or formation. GM, geometric mean; SE, standard error. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. One participant did not have P1NP measured. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 76 |
GM - SE, BSAP, n=64, 76 |
-5.6
|
4.3
|
GM, BSAP, n=64, 76 |
-2.0
|
8.0
|
GM + SE, BSAP, n=64, 76 |
1.8
|
11.8
|
GM - SE, P1NP, n=63, 76 |
-15.8
|
3.2
|
GM, P1NP, n=63, 76 |
-12.4
|
7.0
|
GM + SE, P1NP, n=63, 76 |
-9.0
|
11.0
|
Title | Adjusted Percent Change From Baseline in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) at Week 52 and Week 76 |
---|---|
Description | CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 77 | 84 |
Week 52, GM - SE, n=77, 84 |
11.3
|
-7.8
|
Week 52, GM, n=77, 84 |
18.1
|
-2.3
|
Week 52, GM + SE, n=77, 84 |
25.4
|
3.7
|
Week 76, GM - SE, n=63, 77 |
-19.5
|
-4.5
|
Week 76, GM, n=63, 77 |
-13.1
|
2.6
|
Week 76, GM + SE, n=63, 77 |
-6.1
|
10.3
|
Title | Adjusted Percent Change in Carboxyterminal Cross-linked Telopeptide of Type 1 Collagen (CTX) From Week 52 to Week 76 |
---|---|
Description | CTX levels were measured in picograms per milliliter (pg/ml) from blood samples. CTX is an indicator of bone break down or resorption. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 76 |
GM - SE |
-31.2
|
2.2
|
GM |
-26.7
|
8.4
|
GM + SE |
-21.9
|
14.9
|
Title | Adjusted Percent Change From Baseline in 25-Hydroxyvitamin D (Vitamin D) at Week 52 and Week 76 |
---|---|
Description | Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 61 | 65 |
Week 52, GM - SE, n=61, 65 |
-27.9
|
-15.9
|
Week 52, GM, n=61, 65 |
-24.7
|
-12.2
|
Week 52, GM + SE, n=61, 65 |
-21.4
|
-8.4
|
Week 76, GM - SE, n=55, 58 |
-21.3
|
-12.5
|
Week 76, GM, n=55, 58 |
-18.1
|
-8.9
|
Week 76, GM + SE, n=55, 58 |
-14.6
|
-5.2
|
Title | Adjusted Percent Change in 25-Hydroxyvitamin D (Vitamin D) From Week 52 to Week 76 |
---|---|
Description | Vitamin D levels were measured in nanomoles per Liter (nmol/L) from blood samples. Vitamin D is required for good bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 63 | 76 |
GM - SE |
-4.7
|
-7.7
|
GM |
0.1
|
-3.2
|
GM + SE |
5.1
|
1.5
|
Title | Adjusted Percent Change From Baseline in Intact Parathyroid Hormone (PTH) at Week 52 and Week 76 |
---|---|
Description | Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 71 |
Week 52, GM - SE, n=64, 71 |
-16.5
|
-25.9
|
Week 52, GM, n=64, 71 |
-12.0
|
-22.0
|
Week 52, GM + SE, n=64, 71 |
-7.2
|
-17.8
|
Week 76, GM - SE, n=56, 64 |
-28.8
|
-26.2
|
Week 76, GM, n=56, 64 |
-23.1
|
-20.8
|
Week 76, GM + SE, n=56, 64 |
-17.0
|
-15.0
|
Title | Adjusted Percent Change in Intact Parathyroid Hormone (PTH) From Week 52 to Week 76 |
---|---|
Description | Intact PTH levels were measured in nanograms per Liter (ng/L) from blood samples. Intact PTH is the amount of PTH circulating in the blood and influences bone health. Percent change was based on log-transformed data and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 75 |
GM - SE |
-13.2
|
-1.7
|
GM |
-7.4
|
4.3
|
GM + SE |
-1.3
|
10.7
|
Title | Percent Change From Baseline in Serum Estradiol at Week 52 and Week 76 |
---|---|
Description | Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 74 | 82 |
Week 52, GM - SE, n=74, 82 |
-17.0838
|
-31.4166
|
Week 52, GM, n=74, 82 |
-3.453
|
-17.280
|
Weel 52, GM + SE, n=74, 82 |
12.4189
|
-0.2292
|
Week 76, GM - SE, n=64, 76 |
-16.0971
|
0.4372
|
Week 76, GM, n=64, 76 |
0.215
|
21.389
|
Week 76, GM + SE, n=64, 76 |
19.6987
|
46.7122
|
Title | Percent Change in Serum Estradiol From Week 52 to Week 76 |
---|---|
Description | Serum estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Estradiol is one form of the female sex hormone estrogen and influences bone health. Percent change from baseline was based on log-transformed data. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 77 |
GM - SE |
-15.2056
|
29.3058
|
GM |
0.513
|
50.823
|
GM + SE |
19.1447
|
75.9217
|
Title | Percent Change From Baseline in Total Testosterone at Week 52 and Week 76 |
---|---|
Description | Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 74 | 82 |
Week 52, GM - SE, n=74, 82 |
14.1569
|
-5.8206
|
Week 52, GM, n=74, 82 |
19.689
|
1.044
|
Week 52, GM + SE, n=74, 82 |
25.4897
|
8.4082
|
Week 76, GM - SE, n=64, 75 |
-12.5441
|
-8.2870
|
Week 76, GM, n=64, 75 |
-8.156
|
-2.932
|
Week 76, GM + SE, n=64, 75 |
-3.5470
|
2.7363
|
Title | Percent Change in Total Testosterone From Week 52 to Week 76 |
---|---|
Description | Total testosterone levels were measured in nanomoles per Liter (nmol/L) from blood samples. Testosterone is a male sex hormone and influences bone health; total testosterone is the entire amount circulating in blood. Percent change from baseline was based on log-transformed data. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 76 |
GM - SE |
-29.0307
|
-13.9923
|
GM |
-24.373
|
-7.102
|
GM + SE |
-19.4104
|
0.3411
|
Title | Percent Change From Baseline in Free Testosterone at Week 52 and Week 76 |
---|---|
Description | Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 74 | 82 |
Week 52, GM - SE, n=74, 82 |
-9.9964
|
2.5725
|
Week 52, GM, n=74, 82 |
-5.940
|
6.266
|
Week 52, GM + SE, n=74, 82 |
1.7006
|
10.0934
|
Week 76, GM - SE, n=64, 75 |
-0.3232
|
-1.9532
|
Week 76, GM, n=64, 75 |
3.687
|
2.478
|
Week 76, GM + SE, n=64, 75 |
7.8593
|
7.1093
|
Title | Percent Change in Free Testosterone From Week 52 to Week 76 |
---|---|
Description | Free testosterone levels were measured as a percentage of total testosterone from blood samples. Free testosterone is the amount of testosterone available to the body for use. Percent change from baseline was based on log-transformed data. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 76 |
GM - SE |
3.1109
|
-6.9549
|
GM |
8.993
|
-3.537
|
GM + SE |
15.2100
|
0.0073
|
Title | Percent Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Week 52 and Week 76 |
---|---|
Description | SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 74 | 83 |
Week 52, GM - SE, n=74, 83 |
33.2608
|
4.3929
|
Week 52, GM, n=74, 83 |
37.563
|
8.146
|
Week 52, GM + SE, n=74, 83 |
42.0049
|
12.0349
|
Week 76, GM - SE, n=61, 67 |
-0.2973
|
4.0983
|
Week 76, GM, n=61, 67 |
3.137
|
9.846
|
Week 76, GM + SE, n=61, 67 |
6.6896
|
15.9116
|
Title | Percent Change in Sex Hormone Binding Globulin (SHBG) From Week 52 to Week 76 |
---|---|
Description | SHBG levels were measured in nanomoles per liter (nmol/L) from blood samples. SHBG binds to estradiol and testosterone and influences the amount of estradiol or testosterone available to the body for use. Percent change from baseline was based on log-transformed data. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 62 | 66 |
GM - SE |
-27.0129
|
-3.9036
|
GM |
-24.624
|
-0.825
|
GM + SE |
-22.1566
|
2.3517
|
Title | Percent Change in Percentage of Free Estradiol From Week 52 to Week 76 |
---|---|
Description | Free estradiol levels were measured as a percentage of serum estrogen from blood samples. Free estradiol is the amount of estrogen available to the body for use. Percent change was based on log-transformed data. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 33 | 38 |
GM - SE |
-7.6337
|
-5.4666
|
GM |
-2.683
|
-0.975
|
GM + SE |
2.5337
|
3.7301
|
Title | Percent Change in Free Estradiol From Week 52 to Week 76 |
---|---|
Description | Free estradiol levels were measured in picomoles per Liter (pmol/L) from blood samples. Free estrodial is the amount of estrogen available to the body for use. Change was based on log-transformed data. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 27 | 33 |
GM - SE |
-29.5250
|
96.1843
|
GM |
-3.239
|
173.932
|
GM + SE |
32.8525
|
282.4903
|
Title | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 10 Days and Week 76 + 10 Days |
---|---|
Description | BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 10 days or Week 76 + 10 days was calculated as (BMD at Week 52 + 10 days (or Week 76 + 10 days ) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 10 days, and Week 76 + 10 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 10 days after initiating OL MET or at Week 76 performed up to 10 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for the DXA lumbar spine measurement. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 70 | 78 |
Week 52 + 10 days; Femoral neck (FN), n=70, 78 |
-1.47
(0.521)
|
0.22
(0.512)
|
Week 52 + 10 days; Total hip (TH), n=70, 78 |
-1.62
(0.386)
|
-0.72
(0.379)
|
Week 52 + 10 days; Trochanter (Tro.), n=70, 78 |
-1.45
(0.602)
|
-1.04
(0.589)
|
Week 52 + 10 days; Lumbar spine (LS), n=70, 76 |
-1.41
(0.416)
|
0.04
(0.419)
|
Week 76 + 10 days; FN, n=65, 70 |
-1.91
(0.624)
|
0.31
(0.636)
|
Week 76 + 10 days; TH, n=65, 70 |
-1.70
(0.415)
|
-0.83
(0.420)
|
Week 76 + 10 days; Tro., n=65, 70 |
-2.14
(0.644)
|
-1.35
(0.650)
|
Week 76 + 10 days; LS, n=65, 71 |
-1.24
(0.452)
|
0.85
(0.457)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Lumbar Spine BMD Via DXA at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | BMD (measured in grams per centimeters squared [g/cm^2]) was measured by DXA. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (BMD at Week 52 + 30 days (or Week 76 + 30 days) minus BMD at Baseline)/BMD at Baseline x 100% and was assessed by analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. Not all participants had the correct positioning for all of the DXA measurements. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 79 | 83 |
Week 52 + 30 days; Femoral neck (FN), n=77, 83 |
-1.59
(0.503)
|
0.24
(0.498)
|
Week 52 + 30 days; Total hip (TH), n=77, 83 |
-1.79
(0.370)
|
-0.72
(0.364)
|
Week 52 + 30 days; Trochanter (Tro.), n=77, 83 |
-1.83
(0.583)
|
-1.01
(0.574)
|
Week 52 + 30 days; Lumbar spine (LS), n=79, 81 |
-1.60
(0.417)
|
0.11
(0.421)
|
Week 76 + 30 days; FN, n=66, 74 |
-2.05
(0.620)
|
0.29
(0.619)
|
Week 76 + 30 days; TH, n=66, 74 |
-1.79
(0.408)
|
-0.68
(0.404)
|
Week 76 + 30 days; Tro., n=66, 74 |
-2.53
(0.508)
|
-0.96
(0.575)
|
Week 76 + 30 days; LS, n=66, 72 |
-1.15
(0.464)
|
1.13
(0.467)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (BMD at Week 52 + 30 days (orWeek 76 + 30 days) minus BMD at baseline)/BMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days; Femoral neck (FN), n=32, 35 |
-2.39
(0.895)
|
0.09
(0.986)
|
Week 52 + 30 days; Total hip (TH), n=32, 35 |
-3.39
(0.475)
|
0.09
(0.521)
|
Week 52 + 30 days; Trochanter (Tro.), n=32, 35 |
-4.53
(0.612)
|
-0.23
(0.669)
|
Week 52+30 days; Intertrochanter (Inter.),n=32, 35 |
-3.36
(0.515)
|
0.77
(0.565)
|
Week 76+30 days; Femoral neck (FN), n=31, 30 |
-1.98
(0.587)
|
-1.52
(0.705)
|
Week 76 + 30 days; TH, n=31, 30 |
-2.11
(0.495)
|
-0.32
(0.591)
|
Week 76 + 30 days; Tro., n=31, 30 |
-2.86
(0.752)
|
-1.28
(0.892)
|
Week 76 + 30 days; Inter., n=31, 30 |
-1.66
(0.525)
|
0.30
(0.627)
|
Title | Adjusted Percent Change in Femoral Neck, Total Hip, Trochanter, and Intertrochanter Areal BMD Via Quantitative Computed Tomography (QCT) From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | BMD (measured in grams per centimeters squared [g/cm^2]) was measured by QCT. BMD by QCT is the 2-dimensional volume that mimics the DXA measurement for the same region. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (BMD at Week 76 + 30 days minus BMD at Week 52 + 30 days)/BMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
percent change |
0.95
(0.728)
|
-1.39
(0.866)
|
Total hip |
1.61
(0.346)
|
-0.18
(0.411)
|
Trochanter |
1.81
(0.534)
|
-0.91
(0.632)
|
Intertrochanter |
2.05
(0.428)
|
-0.25
(0.507)
|
Title | Adjusted Percent Change From Baseline in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT at Week 52 + 30 Days and at Week 76 + 30 Days |
---|---|
Description | Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Baseline was calculated as (vBMD at Week 52+30 days (or Week 76+30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days; Integral, n=32, 35 |
-3.60
(0.587)
|
0.99
(0.645)
|
Week 52 + 30 days; Trabecular, n=32, 35 |
-3.63
(1.243)
|
0.21
(1.376)
|
Week 52 + 30 days; Cortical, n=32, 35 |
-0.54
(0.537)
|
0.52
(0.603)
|
Week 76 + 30 days; Integral, n=31, 30 |
-1.70
(0.657)
|
0.85
(0.786)
|
Week 76 + 30 days; Trabecular, n=31, 30 |
-2.66
(1.211)
|
0.70
(1.445)
|
Week 76 + 30 days; Cortical, n=31, 30 |
0.23
(0.421)
|
0.50
(0.518)
|
Title | Adjusted Percent Change in Total Hip (TH) Integral, TH Trabecular, and TH Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | Volumetric (v)BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. vBMD is the 3-dimensional density of a region of bone. Cortical bone is dense bone. Trabecular bone is spongy bone. Integral bone is the sum of cortical and trabecular bone measurements. Cortical thickness is the width of the cortical shell. Percent change from Week 52 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/ vBMD at Week 52 + 30 days x 100% and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Integral |
2.24
(0.483)
|
-0.20
(0.5746)
|
Trabecular |
0.90
(1.252)
|
1.15
(1.491)
|
Cortical |
0.94
(0.449)
|
-0.06
(0.548)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, Integral, n=32, 35 |
-3.72
(1.097)
|
0.58
(1.208)
|
Week 52 + 30 days, Trabecular, n=32, 35 |
-1.83
(1.695)
|
0.91
(1.867)
|
Week 52 + 30 days, Cortical, n=32, 35 |
-1.00
(0.735)
|
-0.20
(0.819)
|
Week 76 + 30 days, Integral, n=31, 30 |
-2.13
(0.946)
|
-0.61
(1.141)
|
Week 76 + 30 days, Trabecular, n=31, 30 |
-1.05
(1.798)
|
2.27
(2.141)
|
Week 76 + 30 days, Cortical, n=31, 30 |
-0.46
(0.599)
|
-1.60
(0.723)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Integral, FN Trabecular, and FN Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Integral |
2.21
(0.871)
|
-1.37
(1.040)
|
Trabecular |
0.27
(1.721)
|
2.21
(2.044)
|
Cortical |
1.03
(0.774)
|
-1.30
(0.929)
|
Title | Adjusted Percent Change From Baseline in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, Integral, n=32, 35 |
-4.80
(0.666)
|
0.01
(0.730)
|
Week 52 + 30 days, Trabecular, n=32, 35 |
-3.43
(1.157)
|
0.67
(1.275)
|
Week 52 + 30 days, Cortical, n=32, 35 |
-1.26
(0.490)
|
-0.18
(0.540)
|
Week 76 + 30 days, Integral, n=31, 30 |
-2.88
(0.748)
|
-0.93
(0.889)
|
Week 76 + 30 days, Trabecular, n=31, 30 |
-2.42
(1.085)
|
0.92
(1.293)
|
Week 76 + 30 days, Cortical, n=31, 30 |
-0.49
(0.384)
|
-0.64
(0.462)
|
Title | Adjusted Percent Change in Trochanter Integral, Trochanter Trabecular, and Trochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
percent change |
2.22
(0.506)
|
-0.90
(0.600)
|
Trabecular |
1.07
(1.138)
|
0.95
(1.353)
|
Cortical |
0.78
(0.396)
|
-0.65
(0.474)
|
Title | Adjusted Percent Change From Baseline in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, Integral, n=32, 35 |
-3.47
(0.621)
|
2.18
(0.683)
|
Week 52 + 30 days, Trabecular, n=32, 35 |
-4.26
(1.341)
|
-0.22
(1.485)
|
Week 52 + 30 days, Cortical, n=32, 35 |
-0.76
(0.568)
|
0.99
(0.631)
|
Week 76 + 30 days, Integral, n=31, 30 |
-0.92
(0.746)
|
1.88
(0.895)
|
Week 76 + 30 days, Trabecular, n=31, 30 |
-3.09
(1.278)
|
0.27
(1.525)
|
Week 76 + 30 days, Cortical, n=31, 30 |
0.41
(0.472)
|
0.79
(0.573)
|
Title | Adjusted Percent Change in Intertrochanter Integral, Intertrochanter Trabecular, and Intertrochanter Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
percent change |
2.83
(0.563)
|
-0.46
(0.671)
|
Trabecular |
1.16
(1.298)
|
1.21
(1.545)
|
Cortical |
1.29
(0.479)
|
-0.27
(0.577)
|
Title | Adjusted Percent Change From Baseline in Vertebral Trabecular vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, n=32, 35 |
-6.71
(1.454)
|
-1.72
(1.601)
|
Week 76 + 30 days, n=31, 30 |
-5.15
(1.121)
|
-3.91
(1.337)
|
Title | Adjusted Percent Change in Vertebral Trabecular vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | BMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [percent change] |
3.53
(1.454)
|
-2.11
(1.727)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days orWeek 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, Integral, n=32, 35 |
-10.26
(2.194)
|
-0.03
(2.417)
|
Week 52 + 30 days, Trabecular, n=32, 35 |
2.77
(5.848)
|
5.57
(6.420)
|
Week 52 + 30 days, Cortical, n=32, 35 |
-3.76
(0.836)
|
-0.66
(0.922)
|
Week 76 + 30 days, Integral, n=31, 30 |
-4.21
(2.094)
|
1.07
(2.508)
|
Week 76 + 30 days, Trabecular, n=31, 30 |
2.37
(7.040)
|
10.24
(8.362)
|
Week 76 + 30 days, Cortical, n=31, 30 |
-1.65
(0.730)
|
-1.30
(0.877)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior and Cortical vBMD Via QCT at Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-posterior is the upper and back section of the FN. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [mg/cm^3] |
-8.007
(3.4199)
|
-7.006
(4.1114)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Integral |
8.29
(3.262)
|
0.52
(3.884)
|
Trabecular |
36.05
(31.815)
|
-11.69
(37.721)
|
Cortical |
2.17
(0.944)
|
-0.94
(1.129)
|
Title | Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therpay, and region. Supero-posterior is the upper and back section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [mg/cm^3] |
9.30
(4.287)
|
-4.92
(5.130)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100% |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, n=32, 35 |
-20.48
(3.614)
|
1.00
(3.986)
|
Week 76 + 30 days, n=31,30 |
-3.52
(3.674)
|
-1.50
(4.423)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [millimeters] |
-0.95
(0.0537)
|
-0.067
(0.0647)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [percent change] |
32.42
(10.358)
|
-7.80
(2.383)
|
Title | Adjusted Change in Femoral Neck (FN) Supero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [millimeters] |
0.18
(0.049)
|
-0.05
(0.059)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 daysor Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days(or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. |
Time Frame | Baseline, Week 52 plus 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, Integral, n=32, 35 |
-6.56
(2.106)
|
-0.58
(2.311)
|
Week 52 + 30 days, Trabecular, n=32, 35 |
3.59
(4.719)
|
2.82
(5.180)
|
Week 52 + 30 days, Cortical, n=32, 35 |
-1.91
(0.901)
|
-0.25
(0.977)
|
Week 76 + 30 days, Integral, n=31, 30 |
-4.97
(2.384)
|
-2.45
(2.838)
|
Week 76 + 30 days, Trabecular, n=31, 30 |
-0.85
(6.050)
|
3.98
(7.171)
|
Week 76 + 30 days, Cortical, n=31, 30 |
-0.93
(0.745)
|
-1.49
(0.876)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [mg/cm^3] |
-4.555
(3.5006)
|
-7.553
(4.1177)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Integral |
2.96
(2.202)
|
-1.81
(2.609)
|
Trabecular |
-2.78
(4.677)
|
6.63
(5.531)
|
Cortical |
1.19
(0.778)
|
-1.28
(0.912)
|
Title | Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Supero-anterior is the upper and front section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [mg/cm^3] |
5.19
(3.686)
|
-6.24
(4.319)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days(or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, n=32, 35 |
-13.45
(5.002)
|
5.05
(5.453)
|
Week 76 + 30 days, n=31, 30 |
-4.23
(4.491)
|
-4.78
(5.327)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change from baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [millimeters] |
-0.117
(0.0484)
|
-0.087
(0.0575)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [percent change] |
14.02
(6.779)
|
-13.65
(7.995)
|
Title | Adjusted Change in Femoral Neck (FN) Supero-anterior Cortical Thickness Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [millimeters] |
0.11
(0.052)
|
-0.13
(0.061)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (or Week 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, Integral, n=32, 35 |
-4.11
(1.074)
|
1.74
(1.200)
|
Week 52 + 30 days, Trabecular, n=32, 35 |
-84.08
(270.700)
|
282.16
(297.445)
|
Week 52 + 30 days, Cortical, n=32, 35 |
-3.42
(1.531)
|
1.14
(1.694)
|
Week 76 + 30 days, Integral, n=31, 30 |
-3.11
(0.933)
|
0.01
(1.147)
|
Week 76 + 30 days, Trabecular, n=31, 30 |
24.46
(17.473)
|
13.54
(20.790)
|
Week 76 + 30 days, Cortical, n=31, 30 |
-1.32
(1.234)
|
-1.17
(1.492)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT at Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [mg/cm^3] |
-12.424
(8.9945)
|
-10.244
(10.8703)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Integral |
1.47
(1.183)
|
-1.87
(1.435)
|
Trabecular |
-39.81
(130.071)
|
161.81
(154.179)
|
Cortical |
2.67
(1.728)
|
-2.50
(2.076)
|
Title | Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-posterior is the lower and back section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [mg/cm^3] |
15.48
(11.544)
|
-17.59
(13.865)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (or Week 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, n=32, 35 |
0.47
(1.977)
|
-1.27
(2.180)
|
Week 76 + 30 days, n=31, 30 |
-1.46
(1.593)
|
-0.11
(1.910)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT at Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change from Baseline was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [millimeters] |
-0.082
(0.0816)
|
-0.048
(0.0978)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [percent change] |
-1.48
(1.552)
|
2.04
(1.846)
|
Title | Adjusted Change in Femoral Neck (FN) Infero-posterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [millimeters] |
-0.08
(0.078)
|
0.07
(0.093)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Baseline at Week 52 + 30 days or Week 76 + 30 days was calculated as (vBMD at Week 52 + 30 days (orWeek 76 + 30 days) minus vBMD at baseline)/vBMD at Baseline x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, Integral, n=32, 35 |
-4.35
(1.950)
|
1.26
(2.163)
|
Week 52, Trabecular, n=32, 35 |
-161.59
(774.589)
|
930.71
(851.727)
|
Week 52, Cortical, n=32, 35 |
-1.85
(1.309)
|
0.85
(1.563)
|
Week 76 + 30 days, Integral, n=31, 30 |
-0.29
(2.301)
|
0.54
(2.810)
|
Week 76 + 30 days, Trabecular, n=31, 30 |
81.29
(35.959)
|
37.81
(42.791)
|
Week 76 + 30 days, Cortical, n=31, 30 |
1.45
(1.149)
|
-0.63
(1.409)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT at Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Baseline at Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at baseline and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [mg/cm^3] |
7.901
(6.9912)
|
-5.025
(8.5722)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Integral, Trabecular, and Cortical vBMD Via QCT From Week 52+30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD (measured in milligrams per centimeters cubed [mg/cm^3]) was measured by QCT. Percent change from Week 52 + 30 days to Week 76 + 30 days was calculated as (vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days)/vBMD at Week 52 + 30 days x 100% and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Integral |
5.05
(1.878)
|
0.38
(2.268)
|
Trabecular |
-90.60
(167.792)
|
260.13
(199.323)
|
Cortical |
3.68
(1.649)
|
-1.64
(2.016)
|
Title | Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical vBMD Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | vBMD was measured by QCT. Change from Week 52 + 30 days to Week 76 + 30 days was calculated as vBMD at Week 76 + 30 days minus vBMD at Week 52 + 30 days and was assessed by an analysis of covariance (ANCOVA) with terms for treatment, baseline value, prior therapy, and region. Infero-anterior is the lower and front section of the FN. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [mg/cm^3] |
20.15
(9.677)
|
-10.73
(11.830)
|
Title | Adjusted Percent Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 52 + 30 Days and Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 52 + 30 days (orWeek 76 + 30 days) minus thickness at Baseline)/thickness at Baseline x 100%. |
Time Frame | Baseline, Week 52 + 30 days, and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 32 | 35 |
Week 52 + 30 days, n=32, 35 |
-6.05
(2.393)
|
0.64
(2.656)
|
Week 76 + 30 days, n=31, 30 |
-3.59
(2.804)
|
0.39
(3.421)
|
Title | Adjusted Change From Baseline in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT at Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Baseline. |
Time Frame | Baseline and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Baseline and at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 31 | 30 |
Mean (Standard Error) [millimeters] |
-0.120
(0.0931)
|
-0.040
(0.1135)
|
Title | Adjusted Percent Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness (measured in millimeters) was measured by QCT. Percent change was calculated as (thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days)/thickness at Week 52 + 30 days x 100%. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [percent change] |
3.12
(2.127)
|
1.56
(2.257)
|
Title | Adjusted Change in Femoral Neck (FN) Infero-anterior Cortical Thickness Via QCT From Week 52 + 30 Days to Week 76 + 30 Days |
---|---|
Description | Cortical thickness was measured by QCT. Change was calculated as thickness at Week 76 + 30 days minus thickness at Week 52 + 30 days. |
Time Frame | Week 52 + 30 days and Week 76 + 30 days |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population, QCT subset. Only evaluable participants with a value at Week 52 performed up to 30 days after initiating OL MET or at Week 76 performed up to 30 days after stopping OL MET for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 30 | 30 |
Mean (Standard Error) [millimeters] |
0.09
(0.065)
|
0.01
(0.078)
|
Title | Adjusted Change From Baseline in Albumin-adjusted Serum Calcium (AASC) at Week 52 and Week 76 |
---|---|
Description | AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from baseline was calculated as the Week 52or Week 76 value minus the baseline value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Baseline, Week 52, and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Baseline and at Week 52 or Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 73 | 83 |
Week 52, n=73, 83 |
0.01
(0.009)
|
0.03
(0.009)
|
Week 76, n=64, 75 |
0.03
(0.010)
|
0.04
(0.010)
|
Title | Adjusted Change in Albumin-adjusted Serum Calcium (AASC) From Week 52 to Week 76 |
---|---|
Description | AASC levels were measured from blood samples. AASC is the amount of free calcium circulating in the blood and calcium is required for good bone health. Change from Week 52 was calculated as the Week 76 value minus the Week 52 value and was assessed by an ANCOVA with terms for treatment, baseline value, prior therapy, and region. |
Time Frame | Week 52 and Week 76 |
Outcome Measure Data
Analysis Population Description |
---|
Safety Population. Only evaluable participants with a value at Week 52 and at Week 76 for the parameter of interest were analyzed. |
Arm/Group Title | Rosiglitazone in DB Period; Metformin in OL Period | Metformin in DB Period; Metformin in OL Period |
---|---|---|
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg) in the 52-week DB Period. RSG could be uptitrated to a total daily dose of 8 mg at Week 4. At Week 52, all participants were switched to open-label (OL) Metformin (MET) therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | Metformin (MET) initiated at a total daily dose of 1000 mg in the 52-week DB Period. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4. At Week 52, all participants were switched to open-label MET therapy for 24 weeks during the follow-up phase; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. |
Measure Participants | 64 | 74 |
Mean (Standard Error) [millimoles per Liter (mmol/L)] |
0.01
(0.011)
|
0.00
(0.010)
|
Adverse Events
Time Frame | 76 weeks | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Serious adverse events (SAEs) and AEs were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication. | |||||||
Arm/Group Title | Rosiglitazone: DB | Metformin: DB | Rosiglitazone: MET OL | Metformin: MET OL | ||||
Arm/Group Description | Rosiglitazone (RSG) initiated at a total daily dose of 4 milligrams (mg). RSG could be uptitrated to a total daily dose of 8 mg at Week 4 in the 52-week Double-Blind (DB) Period. | Metformin (MET) initiated at a total daily dose of 1000 mg. MET could be uptitrated to 1500 mg/day at Week 2 and to 2000 mg/day at Week 4 in the 52-week DB Period. | At Week 52, all participants receiving RSG in the DB Period were switched to open-label Metformin (MET) therapy for 24 weeks during the Open-label (OL) Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | At Week 52, all participants receiving MET in the DB Period were switched to open-label MET therapy for 24 weeks during the OL Period; all participants were force-titrated from 1000 mg/day to 2000 mg/day over a 4-week period. However, participants could be down-titrated to alleviate any MET-related tolerability issues. | ||||
All Cause Mortality |
||||||||
Rosiglitazone: DB | Metformin: DB | Rosiglitazone: MET OL | Metformin: MET OL | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
Rosiglitazone: DB | Metformin: DB | Rosiglitazone: MET OL | Metformin: MET OL | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/114 (6.1%) | 5/111 (4.5%) | 0/76 (0%) | 0/84 (0%) | ||||
Cardiac disorders | ||||||||
Coronary artery disease | 0/114 (0%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Gastrointestinal disorders | ||||||||
Umbilical hernia, obstructive | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
General disorders | ||||||||
Device dislocation | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Generalised oedema | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Sudden cardiac death | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Infections and infestations | ||||||||
Urinary tract infection | 1/114 (0.9%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Enteritis infectious | 0/114 (0%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Escherichia infection | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Pyelonephritis | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Injury, poisoning and procedural complications | ||||||||
Wrist fracture | 0/114 (0%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Investigations | ||||||||
Alanine aminotransferase increased | 0/114 (0%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Nervous system disorders | ||||||||
Cerebral infarction | 0/114 (0%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Presyncope | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Asthma | 0/114 (0%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Pleural effusion | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Vascular disorders | ||||||||
Hypertension | 1/114 (0.9%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
Rosiglitazone: DB | Metformin: DB | Rosiglitazone: MET OL | Metformin: MET OL | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 47/115 (40.9%) | 45/111 (40.5%) | 12/76 (15.8%) | 8/84 (9.5%) | ||||
Gastrointestinal disorders | ||||||||
Diarrhoea | 3/115 (2.6%) | 15/111 (13.5%) | 6/76 (7.9%) | 1/84 (1.2%) | ||||
Dyspepsia | 2/115 (1.7%) | 6/111 (5.4%) | 0/76 (0%) | 0/84 (0%) | ||||
Nausea | 3/115 (2.6%) | 3/111 (2.7%) | 3/76 (3.9%) | 5/84 (6%) | ||||
General disorders | ||||||||
Oedemal peripheral | 17/115 (14.8%) | 0/111 (0%) | 0/76 (0%) | 0/84 (0%) | ||||
Fatigue | 6/115 (5.2%) | 4/111 (3.6%) | 0/76 (0%) | 0/84 (0%) | ||||
Infections and infestations | ||||||||
Nasopharyngitis | 7/115 (6.1%) | 7/111 (6.3%) | 1/76 (1.3%) | 0/84 (0%) | ||||
Influenza | 3/115 (2.6%) | 6/111 (5.4%) | 0/76 (0%) | 1/84 (1.2%) | ||||
Investigations | ||||||||
Weight increased | 9/115 (7.8%) | 1/111 (0.9%) | 0/76 (0%) | 0/84 (0%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Arthralgia | 5/115 (4.3%) | 6/111 (5.4%) | 1/76 (1.3%) | 0/84 (0%) | ||||
Back pain | 6/115 (5.2%) | 5/111 (4.5%) | 1/76 (1.3%) | 0/84 (0%) | ||||
Nervous system disorders | ||||||||
Headache | 9/115 (7.8%) | 5/111 (4.5%) | 1/76 (1.3%) | 1/84 (1.2%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Cough | 6/115 (5.2%) | 1/111 (0.9%) | 1/76 (1.3%) | 1/84 (1.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title | GSK Response Center |
---|---|
Organization | GlaxoSmithKline |
Phone | 866-435-7343 |
- AVD111179