Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Biological: albiglutideBiological: placebo albiglutideDrug: placebo glimepiride
- Registration Number
- NCT00838903
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1049
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
- females who are pregnant, lactating or <6 weeks post-partum
- current symptomatic heart failure (NYHA Class III or IV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description albiglutide + metformin placebo sitagliptin Albiglutide + metformin + placebo sitagliptin + placebo glimepiride glimepiride + metformin placebo sitagliptin Glimepiride + metformin + placebo albiglutide + placebo sitagliptin metformin + placebo placebo glimepiride Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride glimepiride + metformin placebo albiglutide Glimepiride + metformin + placebo albiglutide + placebo sitagliptin metformin + placebo placebo albiglutide Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride metformin + placebo placebo sitagliptin Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride albiglutide + metformin albiglutide Albiglutide + metformin + placebo sitagliptin + placebo glimepiride albiglutide + metformin placebo glimepiride Albiglutide + metformin + placebo sitagliptin + placebo glimepiride sitagliptin + metformin placebo albiglutide Sitagliptin + metformin + placebo albiglutide + placebo glimepiride sitagliptin + metformin placebo glimepiride Sitagliptin + metformin + placebo albiglutide + placebo glimepiride sitagliptin + metformin metformin Sitagliptin + metformin + placebo albiglutide + placebo glimepiride albiglutide + metformin metformin Albiglutide + metformin + placebo sitagliptin + placebo glimepiride sitagliptin + metformin sitagliptin Sitagliptin + metformin + placebo albiglutide + placebo glimepiride glimepiride + metformin glimepiride Glimepiride + metformin + placebo albiglutide + placebo sitagliptin glimepiride + metformin metformin Glimepiride + metformin + placebo albiglutide + placebo sitagliptin metformin + placebo metformin Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride
- Primary Outcome Measures
Name Time Method Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 Baseline and Week 104 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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Body Weight at Week 104 Baseline and Week 104 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 + Baseline HbA1c category + prior myocardial infarction history + age category + region.
Change From Baseline in HbA1c at Week 156 Baseline and Week 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 .
Change From Baseline in FPG at Week 156 Baseline and Week 156 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. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 Week 104 The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% 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%, \<7%, and \<7.5% at Week 156) were assessed.
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 hyperglycemic 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 week
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 Baseline and Week 104 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 FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region.
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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
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Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom