Study In Postmenopausal Women With Type 2 Diabetes Looking At Approved Diabetes Drugs And How They Affect Bone Health

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00679939
Collaborator
(none)
226
42
2
28.8
5.4
0.2

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

Study Type:
Interventional
Actual Enrollment :
226 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 52 Week Randomized, Double-Blind, Multicenter, Mechanistic Study With a 24 Week Open-Label Follow-Up to Evaluate the Effect of AVANDIA TM on Bone in Postmenopausal Women With Type 2 Diabetes Mellitus
Study Start Date :
Apr 21, 2008
Actual Primary Completion Date :
Sep 16, 2010
Actual Study Completion Date :
Sep 16, 2010

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

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  1. 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.

  2. 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

Ages Eligible for Study:
55 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679939
Other Study ID Numbers:
  • AVD111179
First Posted:
May 19, 2008
Last Update Posted:
Apr 18, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Primary Outcome
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)
3. Primary Outcome
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)
4. Secondary Outcome
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)
5. Secondary Outcome
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)
6. Secondary Outcome
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)
7. Secondary Outcome
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
8. Secondary Outcome
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
9. Secondary Outcome
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
10. Secondary Outcome
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
11. Secondary Outcome
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
12. Secondary Outcome
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
13. Secondary Outcome
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
14. Secondary Outcome
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
15. Secondary Outcome
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
16. Secondary Outcome
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
17. Secondary Outcome
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
18. Secondary Outcome
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
19. Secondary Outcome
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
20. Secondary Outcome
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
21. Secondary Outcome
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
22. Secondary Outcome
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
23. Other Pre-specified Outcome
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
24. Other Pre-specified Outcome
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
25. Post-Hoc Outcome
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)
26. Post-Hoc Outcome
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)
27. Post-Hoc Outcome
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)
28. Post-Hoc Outcome
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)
29. Post-Hoc Outcome
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)
30. Post-Hoc Outcome
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)
31. Post-Hoc Outcome
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)
32. Post-Hoc Outcome
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)
33. Post-Hoc Outcome
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)
34. Post-Hoc Outcome
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)
35. Post-Hoc Outcome
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)
36. Post-Hoc Outcome
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)
37. Post-Hoc Outcome
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)
38. Post-Hoc Outcome
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)
39. Post-Hoc Outcome
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)
40. Post-Hoc Outcome
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)
41. Post-Hoc Outcome
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)
42. Post-Hoc Outcome
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)
43. Post-Hoc Outcome
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)
44. Post-Hoc Outcome
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)
45. Post-Hoc Outcome
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)
46. Post-Hoc Outcome
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)
47. Post-Hoc Outcome
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)
48. Post-Hoc Outcome
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)
49. Post-Hoc Outcome
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)
50. Post-Hoc Outcome
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)
51. Post-Hoc Outcome
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)
52. Post-Hoc Outcome
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)
53. Post-Hoc Outcome
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)
54. Post-Hoc Outcome
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)
55. Post-Hoc Outcome
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)
56. Post-Hoc Outcome
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)
57. Post-Hoc Outcome
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)
58. Post-Hoc Outcome
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)
59. Post-Hoc Outcome
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)
60. Post-Hoc Outcome
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)
61. Post-Hoc Outcome
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)
62. Post-Hoc Outcome
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)
63. Post-Hoc Outcome
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)
64. Post-Hoc Outcome
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)
65. Post-Hoc Outcome
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)
66. Post-Hoc Outcome
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)
67. Post-Hoc Outcome
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)
68. Post-Hoc Outcome
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)
69. Post-Hoc Outcome
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)
70. Post-Hoc Outcome
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)
71. Post-Hoc Outcome
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)
72. Post-Hoc Outcome
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

[Not Specified]

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
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00679939
Other Study ID Numbers:
  • AVD111179
First Posted:
May 19, 2008
Last Update Posted:
Apr 18, 2018
Last Verified:
Mar 1, 2018