Safety and Efficacy of Albiglutide in Type 2 Diabetes
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00849056
Collaborator
(none)
310
331
2
48
0.9
0
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
310 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes Mellitus
Study Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Nov 1, 2011
Actual Study Completion Date
:
Jan 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: placebo + pioglitazone (with or without metformin) Placebo albiglutide weekly injection + pioglitazone (with or without metformin) |
Drug: placebo
placebo weekly subcutaneous injection
|
| Experimental: albiglutide + pioglitazone (with or without metformin) albiglutide weekly injection + pioglitazone (with or without meformin) |
Biological: albiglutide
albiglutide weekly subcutaneous injection
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 [Baseline and Week 52]
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.
Secondary Outcome Measures
- Change From Baseline in HbA1c at Weeks 104 and 156 [Baseline and Weeks 104 and 156]
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
- Time to Hyperglycemia Rescue [From the start of study medication until the end of the treatment (up to Week 156)]
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [Baseline and Week 52]
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 [Baseline and Week 156]
The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.
- Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 [Week 52]
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed.
- Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 [Week 156]
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed.
- Change From Baseline in Body Weight at Week 52 [Baseline and Week 52]
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy.
- Change From Baseline in Body Weight at Week 156 [Baseline and Week 156]
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
type 2 diabetes
-
BMI 20-45kg/m2
Exclusion Criteria:
-
NYHA Class II to IV heart failure
-
females who are pregnant, lactating, or less than 6 weeks post-partum
Contacts and Locations
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| 262 | GSK Investigational Site | Fort Worth | Texas | United States | 76135 |
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| 275 | GSK Investigational Site | Lewisville | Texas | United States | 75067 |
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| 277 | GSK Investigational Site | North Richland Hills | Texas | United States | 76180 |
| 278 | GSK Investigational Site | Odessa | Texas | United States | 79761 |
| 279 | GSK Investigational Site | San Antonio | Texas | United States | 78205 |
| 280 | GSK Investigational Site | San Antonio | Texas | United States | 78215 |
| 281 | GSK Investigational Site | San Antonio | Texas | United States | 78218 |
| 282 | GSK Investigational Site | San Antonio | Texas | United States | 78224 |
| 283 | GSK Investigational Site | San Antonio | Texas | United States | 78229 |
| 284 | GSK Investigational Site | San Antonio | Texas | United States | 78258 |
| 285 | GSK Investigational Site | Schertz | Texas | United States | 78154 |
| 286 | GSK Investigational Site | Sugar Land | Texas | United States | 77479 |
| 287 | GSK Investigational Site | Sugarland | Texas | United States | 77479 |
| 288 | GSK Investigational Site | Bountiful | Utah | United States | 84010 |
| 289 | GSK Investigational Site | Orem | Utah | United States | 84058 |
| 290 | GSK Investigational Site | Salt Lake City | Utah | United States | 84107 |
| 291 | GSK Investigational Site | Salt Lake City | Utah | United States | 84120 |
| 292 | GSK Investigational Site | West Jordan | Utah | United States | 84088 |
| 293 | GSK Investigational Site | West Valley City | Utah | United States | 84120 |
| 294 | GSK Investigational Site | South Burlington | Vermont | United States | 05403 |
| 295 | GSK Investigational Site | Burke | Virginia | United States | 22015 |
| 296 | GSK Investigational Site | Hampton | Virginia | United States | 23666 |
| 297 | GSK Investigational Site | Manassas | Virginia | United States | 20110 |
| 298 | GSK Investigational Site | Norfolk | Virginia | United States | 23502 |
| 299 | GSK Investigational Site | Richmond | Virginia | United States | 23294 |
| 300 | GSK Investigational Site | Suffolk | Virginia | United States | |
| 301 | GSK Investigational Site | Weber City | Virginia | United States | 24290 |
| 302 | GSK Investigational Site | Federal Way | Washington | United States | 98003 |
| 303 | GSK Investigational Site | Renton | Washington | United States | 98057 |
| 304 | GSK Investigational Site | Richland | Washington | United States | 99352 |
| 305 | GSK Investigational Site | Selah | Washington | United States | 98942 |
| 306 | GSK Investigational Site | Spokane | Washington | United States | 99208 |
| 307 | GSK Investigational Site | Spokane | Washington | United States | 99216 |
| 308 | GSK Investigational Site | Tacoma | Washington | United States | 98405 |
| 309 | GSK Investigational Site | Lewisburg | West Virginia | United States | 24901 |
| 310 | GSK Investigational Site | Milwaukee | Wisconsin | United States | 53226 |
| 311 | GSK Investigational Site | Aurangabad | India | 431001 | |
| 312 | GSK Investigational Site | Pune | India | 411011 | |
| 313 | GSK Investigational Site | Seongnam-si | Korea, Republic of | 463712 | |
| 314 | GSK Investigational Site | Suwon, Kyonggi-do | Korea, Republic of | 443-721 | |
| 315 | GSK Investigational Site | El Agustino | Lima | Peru | 10 |
| 316 | GSK Investigational Site | Huacho | Lima | Peru | |
| 317 | GSK Investigational Site | Arequipa | Peru | 54 | |
| 318 | GSK Investigational Site | Lima | Peru | 17 | |
| 319 | GSK Investigational Site | Trujillo | Peru | ||
| 320 | GSK Investigational Site | Port Elizabeth | Eastern Cape | South Africa | 6014 |
| 321 | GSK Investigational Site | Phoenix | KwaZulu- Natal | South Africa | 4068 |
| 322 | GSK Investigational Site | Kempton Park | South Africa | 1619 | |
| 323 | GSK Investigational Site | Somerset West | South Africa | 07129 | |
| 324 | GSK Investigational Site | Canterbury | Kent | United Kingdom | CT1 3HX |
| 325 | GSK Investigational Site | Blackpool | Lancashire | United Kingdom | FY4 3AD |
| 326 | GSK Investigational Site | Sunbury-on-Thames | Middlesex | United Kingdom | TW16 6RH |
| 327 | GSK Investigational Site | Port Glasgow | Renfrewshire | United Kingdom | PA14 6HW |
| 328 | GSK Investigational Site | Coventry | West Midlands | United Kingdom | CV2 2DX |
| 329 | GSK Investigational Site | Glasgow | United Kingdom | G45 9AW | |
| 330 | GSK Investigational Site | Liverpool | United Kingdom | L9 7AL | |
| 331 | GSK Investigational Site | London | United Kingdom | SE1 9NH |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849056
Other Study ID Numbers:
- 112755
First Posted:
Feb 23, 2009
Last Update Posted:
Jan 9, 2017
Last Verified:
Nov 1, 2016
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 | Participants (par.) who met eligibility criteria and completed a 4-week Run-in/Stabilization Period were then randomized to a 156-week Treatment Period, followed by 8 weeks of post-treatment follow-up. A total of 450 par. were screened; 310 par. were randomized, and 301 par. received >=1 treatment dose. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Period Title: Treatment Period (TP) (156 Weeks) | ||
| STARTED | 151 | 150 |
| COMPLETED | 88 | 100 |
| NOT COMPLETED | 63 | 50 |
| Period Title: Treatment Period (TP) (156 Weeks) | ||
| STARTED | 149 | 149 |
| COMPLETED | 122 | 124 |
| NOT COMPLETED | 27 | 25 |
Baseline Characteristics
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin | Total |
|---|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Total of all reporting groups |
| Overall Participants | 151 | 150 | 301 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
54.9
(9.40)
|
55.2
(9.98)
|
55.0
(9.67)
|
| Gender (Count of Participants) | |||
| Female |
63
41.7%
|
58
38.7%
|
121
40.2%
|
| Male |
88
58.3%
|
92
61.3%
|
180
59.8%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| African American/African Heritage |
20
13.2%
|
19
12.7%
|
39
13%
|
| American Indian or Alaskan Native |
15
9.9%
|
18
12%
|
33
11%
|
| Asian - Central/South Asian Heritage |
1
0.7%
|
2
1.3%
|
3
1%
|
| Asian - East Asian Heritage |
2
1.3%
|
3
2%
|
5
1.7%
|
| Asian - Japanese Heritage |
1
0.7%
|
1
0.7%
|
2
0.7%
|
| Asian - South East Asian Heritage |
2
1.3%
|
0
0%
|
2
0.7%
|
| Native Hawaiian or other Pacific Islander |
2
1.3%
|
1
0.7%
|
3
1%
|
| White - Arabic/North African Heritage |
2
1.3%
|
2
1.3%
|
4
1.3%
|
| White - White/Caucasian/European Heritage |
106
70.2%
|
104
69.3%
|
210
69.8%
|
Outcome Measures
| Title | Change From Baseline in HbA1c at Weeks 104 and 156 |
|---|---|
| Description | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Time Frame | Baseline and Weeks 104 and 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed (represented by n=X, X in the category titles). |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 29 | 72 |
| Week 104, n= 29, 72 |
-0.72
(0.845)
|
-0.92
(1.038)
|
| Week 156, n=26, 54 |
-0.50
(0.805)
|
-0.87
(0.926)
|
| Title | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 |
|---|---|
| Description | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis. |
| Time Frame | Baseline and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population with LOCF: all randomized par. who received >=1 dose of study medication and who had a BL assessment and >=1 post-BL assessment of HbA1c. Only par. with a value at BL and at the specified visit were analyzed. Values were carried forward for par. who were rescued or discontinued from active treatment before Week 52. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 149 | 149 |
| Least Squares Mean (Standard Error) [Percentage of HbA1c in the blood] |
-0.05
(0.071)
|
-0.81
(0.071)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo + Pioglitazone With or Without Metformin, Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -0.75 | |
| Confidence Interval |
(2-Sided) 95% -0.95 to -0.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to Hyperglycemia Rescue |
|---|---|
| Description | Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks. |
| Time Frame | From the start of study medication until the end of the treatment (up to Week 156) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. Only those participants with a value at Baseline and at the specified visit were analyzed. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 149 | 150 |
| Median (95% Confidence Interval) [Weeks] |
52.86
(0.674)
|
NA
(0.812)
|
| Title | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
|---|---|
| Description | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. |
| Time Frame | Baseline and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 149 | 149 |
| Least Squares Mean (Standard Error) [Millimoles per liter (mmol/L)] |
0.35
(0.197)
|
-1.28
(0.197)
|
| Title | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 |
|---|---|
| Description | The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. |
| Time Frame | Baseline and Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 25 | 54 |
| Mean (Standard Deviation) [Millimoles per liter (mmol/L)] |
0.03
(1.950)
|
-1.26
(1.476)
|
| Title | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 |
|---|---|
| Description | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed. |
| Time Frame | Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 149 | 149 |
| HbA1c <6.5% |
8
5.3%
|
37
24.7%
|
| HbA1c <7% |
22
14.6%
|
66
44%
|
| HbA1c <7.5% |
44
29.1%
|
96
64%
|
| Title | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 |
|---|---|
| Description | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed. |
| Time Frame | Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population with observed values. Only those participants with a value at Baseline and at the specified visit were analyzed. This analysis used observed HbA1c values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 26 | 54 |
| HbA1c <6.5% |
7
4.6%
|
20
13.3%
|
| HbA1c <7% |
12
7.9%
|
32
21.3%
|
| HbA1c <7.5% |
17
11.3%
|
44
29.3%
|
| Title | Change From Baseline in Body Weight at Week 52 |
|---|---|
| Description | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. |
| Time Frame | Baseline and Week 52 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population with LOCF. Only those participants with a value at Baseline and at the specified visit were analyzed. Values were carried forward for participants who were rescued or discontinued from active treatment before Week 52. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 149 | 149 |
| Least Squares Mean (Standard Error) [Kilograms] |
0.45
(0.348)
|
0.28
(0.348)
|
| Title | Change From Baseline in Body Weight at Week 156 |
|---|---|
| Description | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. |
| Time Frame | Baseline and Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population with observed values. Only those participants who were available at the indicated time points were analyzed. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. |
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin |
|---|---|---|
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. |
| Measure Participants | 26 | 55 |
| Mean (Standard Deviation) [Kilograms] |
1.50
(6.939)
|
-0.16
(6.284)
|
Adverse Events
| Time Frame | On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment. | |||
| Arm/Group Title | Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin | ||
| Arm/Group Description | Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period. | ||
All Cause Mortality |
||||
| Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/151 (18.5%) | 15/150 (10%) | ||
| Cardiac disorders | ||||
| Coronary artery disease | 2/151 (1.3%) | 2/150 (1.3%) | ||
| Acute myocardial infarction | 0/151 (0%) | 2/150 (1.3%) | ||
| Angina unstable | 0/151 (0%) | 1/150 (0.7%) | ||
| Aortic valve incompetence | 1/151 (0.7%) | 0/150 (0%) | ||
| Atrial fibrillation | 0/151 (0%) | 1/150 (0.7%) | ||
| Cardiac failure | 1/151 (0.7%) | 0/150 (0%) | ||
| Cardiomyopathy | 1/151 (0.7%) | 0/150 (0%) | ||
| Coronary artery stenosis | 1/151 (0.7%) | 0/150 (0%) | ||
| Myocardial infarction | 1/151 (0.7%) | 0/150 (0%) | ||
| Sick sinus syndrome | 1/151 (0.7%) | 0/150 (0%) | ||
| Gastrointestinal disorders | ||||
| Colonic fistula | 0/151 (0%) | 1/150 (0.7%) | ||
| Diabetic gastroparesis | 1/151 (0.7%) | 0/150 (0%) | ||
| Gastric ulcer | 1/151 (0.7%) | 0/150 (0%) | ||
| Gastrooesophageal reflux disease | 0/151 (0%) | 1/150 (0.7%) | ||
| Small intestinal obstruction | 1/151 (0.7%) | 0/150 (0%) | ||
| General disorders | ||||
| Chest pain | 3/151 (2%) | 0/150 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 2/151 (1.3%) | 0/150 (0%) | ||
| Cholecystitis | 0/151 (0%) | 1/150 (0.7%) | ||
| Infections and infestations | ||||
| Cellulitis | 2/151 (1.3%) | 1/150 (0.7%) | ||
| Abscess limb | 1/151 (0.7%) | 1/150 (0.7%) | ||
| Pneumonia | 0/151 (0%) | 2/150 (1.3%) | ||
| Appendicitis perforated | 0/151 (0%) | 1/150 (0.7%) | ||
| Diverticulitis | 1/151 (0.7%) | 0/150 (0%) | ||
| Sinusitis | 1/151 (0.7%) | 0/150 (0%) | ||
| Viral infection | 0/151 (0%) | 1/150 (0.7%) | ||
| Vulval abscess | 1/151 (0.7%) | 0/150 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Face injury | 1/151 (0.7%) | 0/150 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Obesity | 1/151 (0.7%) | 0/150 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 2/151 (1.3%) | 0/150 (0%) | ||
| Osteoarthritis | 1/151 (0.7%) | 1/150 (0.7%) | ||
| Bursitis | 0/151 (0%) | 1/150 (0.7%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer stage I | 1/151 (0.7%) | 0/150 (0%) | ||
| Lung cancer metastatic | 0/151 (0%) | 1/150 (0.7%) | ||
| Metastases to liver | 1/151 (0.7%) | 0/150 (0%) | ||
| Non-small cell lung cancer | 1/151 (0.7%) | 0/150 (0%) | ||
| Prostate cancer metastatic | 0/151 (0%) | 1/150 (0.7%) | ||
| Nervous system disorders | ||||
| Dizziness | 0/151 (0%) | 1/150 (0.7%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Abortion spontaneous | 1/151 (0.7%) | 0/150 (0%) | ||
| Psychiatric disorders | ||||
| Major depression | 1/151 (0.7%) | 0/150 (0%) | ||
| Renal and urinary disorders | ||||
| Nephrolithiasis | 0/151 (0%) | 1/150 (0.7%) | ||
| Renal colic | 0/151 (0%) | 1/150 (0.7%) | ||
| Renal impairment | 1/151 (0.7%) | 0/150 (0%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 2/151 (1.3%) | 0/150 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo + Pioglitazone With or Without Metformin | Albiglutide 30 mg + Pioglitazone With or Without Metformin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 117/151 (77.5%) | 126/150 (84%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 9/151 (6%) | 6/150 (4%) | ||
| Cardiac disorders | ||||
| Palpitations | 0/151 (0%) | 4/150 (2.7%) | ||
| Angina pectoris | 4/151 (2.6%) | 0/150 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 2/151 (1.3%) | 5/150 (3.3%) | ||
| Ear pain | 4/151 (2.6%) | 1/150 (0.7%) | ||
| Eye disorders | ||||
| Cataract | 3/151 (2%) | 7/150 (4.7%) | ||
| Diabetic retinopathy | 2/151 (1.3%) | 7/150 (4.7%) | ||
| Presbyopia | 4/151 (2.6%) | 2/150 (1.3%) | ||
| Refraction disorder | 4/151 (2.6%) | 1/150 (0.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 16/151 (10.6%) | 22/150 (14.7%) | ||
| Nausea | 18/151 (11.9%) | 18/150 (12%) | ||
| Gastrooesophageal reflux disease | 1/151 (0.7%) | 9/150 (6%) | ||
| Vomiting | 6/151 (4%) | 8/150 (5.3%) | ||
| Toothache | 4/151 (2.6%) | 8/150 (5.3%) | ||
| Abdominal pain upper | 6/151 (4%) | 6/150 (4%) | ||
| Constipation | 2/151 (1.3%) | 5/150 (3.3%) | ||
| Dyspepsia | 5/151 (3.3%) | 4/150 (2.7%) | ||
| Gastritis | 3/151 (2%) | 4/150 (2.7%) | ||
| Abdominal pain | 8/151 (5.3%) | 2/150 (1.3%) | ||
| General disorders | ||||
| Oedema peripheral | 16/151 (10.6%) | 15/150 (10%) | ||
| Fatigue | 7/151 (4.6%) | 10/150 (6.7%) | ||
| Injection site reaction | 5/151 (3.3%) | 8/150 (5.3%) | ||
| Injection site haemorrhage | 1/151 (0.7%) | 7/150 (4.7%) | ||
| Injection site haematoma | 4/151 (2.6%) | 6/150 (4%) | ||
| Pyrexia | 4/151 (2.6%) | 3/150 (2%) | ||
| Injection stie pruritis | 5/151 (3.3%) | 0/150 (0%) | ||
| Immune system disorders | ||||
| Seasonal allergy | 5/151 (3.3%) | 5/150 (3.3%) | ||
| Infections and infestations | ||||
| Upper respiratory tract infection | 24/151 (15.9%) | 24/150 (16%) | ||
| Urinary tract infection | 9/151 (6%) | 17/150 (11.3%) | ||
| Sinusitis | 9/151 (6%) | 15/150 (10%) | ||
| Nasopharyngitis | 22/151 (14.6%) | 12/150 (8%) | ||
| Bronchitis | 15/151 (9.9%) | 10/150 (6.7%) | ||
| Gastroenteritis | 2/151 (1.3%) | 7/150 (4.7%) | ||
| Pharyngitis | 7/151 (4.6%) | 6/150 (4%) | ||
| Influenza | 2/151 (1.3%) | 6/150 (4%) | ||
| Cellulitis | 4/151 (2.6%) | 5/150 (3.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Contusion | 9/151 (6%) | 12/150 (8%) | ||
| Laceration | 2/151 (1.3%) | 7/150 (4.7%) | ||
| Meniscus lesion | 2/151 (1.3%) | 4/150 (2.7%) | ||
| Ligament sprain | 4/151 (2.6%) | 3/150 (2%) | ||
| Procedural pain | 4/151 (2.6%) | 3/150 (2%) | ||
| Muscle strain | 5/151 (3.3%) | 2/150 (1.3%) | ||
| Limb injury | 4/151 (2.6%) | 2/150 (1.3%) | ||
| Metabolism and nutrition disorders | ||||
| Hypoglycaemia | 13/151 (8.6%) | 25/150 (16.7%) | ||
| Decreased appetite | 4/151 (2.6%) | 3/150 (2%) | ||
| Dyslipidaemia | 8/151 (5.3%) | 2/150 (1.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 13/151 (8.6%) | 15/150 (10%) | ||
| Back pain | 10/151 (6.6%) | 13/150 (8.7%) | ||
| Musculoskeletal pain | 10/151 (6.6%) | 13/150 (8.7%) | ||
| Osteoarthritis | 6/151 (4%) | 11/150 (7.3%) | ||
| Pain in extremity | 11/151 (7.3%) | 7/150 (4.7%) | ||
| Myalgia | 3/151 (2%) | 6/150 (4%) | ||
| Neck pain | 3/151 (2%) | 5/150 (3.3%) | ||
| Muscle spasms | 7/151 (4.6%) | 4/150 (2.7%) | ||
| Bursitis | 4/151 (2.6%) | 1/150 (0.7%) | ||
| Intervertebral disc protrusion | 4/151 (2.6%) | 0/150 (0%) | ||
| Nervous system disorders | ||||
| Headache | 18/151 (11.9%) | 13/150 (8.7%) | ||
| Dizziness | 5/151 (3.3%) | 10/150 (6.7%) | ||
| Hypoaesthesia | 2/151 (1.3%) | 4/150 (2.7%) | ||
| Neuropathy peripheral | 6/151 (4%) | 2/150 (1.3%) | ||
| Carpal tunnel syndrome | 6/151 (4%) | 1/150 (0.7%) | ||
| Psychiatric disorders | ||||
| Anxiety | 6/151 (4%) | 7/150 (4.7%) | ||
| Depression | 5/151 (3.3%) | 4/150 (2.7%) | ||
| Insomnia | 4/151 (2.6%) | 4/150 (2.7%) | ||
| Renal and urinary disorders | ||||
| Nephrolithiasis | 2/151 (1.3%) | 5/150 (3.3%) | ||
| Renal cyst | 4/151 (2.6%) | 0/150 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 8/151 (5.3%) | 10/150 (6.7%) | ||
| Sinus congestion | 4/151 (2.6%) | 8/150 (5.3%) | ||
| Oropharyngeal pain | 4/151 (2.6%) | 4/150 (2.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pruritis | 1/151 (0.7%) | 5/150 (3.3%) | ||
| Rash | 3/151 (2%) | 4/150 (2.7%) | ||
| Dry skin | 1/151 (0.7%) | 4/150 (2.7%) | ||
| Vascular disorders | ||||
| Hypertension | 15/151 (9.9%) | 17/150 (11.3%) | ||
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 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849056
Other Study ID Numbers:
- 112755
First Posted:
Feb 23, 2009
Last Update Posted:
Jan 9, 2017
Last Verified:
Nov 1, 2016