Safety and Efficacy of Albiglutide in Type 2 Diabetes

Browse trials for

• Diabetes Mellitus 10,926
• Diabetes Mellitus, Type 2 9,362

Keywords

• diabetes

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 310 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Placebo comparator
  placebo + pioglitazone (with or without metformin)

  Placebo albiglutide weekly injection + pioglitazone (with or without metformin)

  Drug: placebo

• Experimental
  albiglutide + pioglitazone (with or without metformin)

  albiglutide weekly injection + pioglitazone (with or without meformin)

  Biological: albiglutide

Interventions

• Biologicalalbiglutide

  albiglutide weekly subcutaneous injection

• Drugplacebo

  placebo weekly subcutaneous injection

Primary outcomes

1. Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at 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.

   Time frame: Baseline and Week 52

Secondary outcomes

1. Change From Baseline in HbA1c at 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 frame: Baseline and Weeks 104 and 156

2. Time to Hyperglycemia Rescue

   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)

3. Change From Baseline in Fasting Plasma Glucose (FPG) at 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.

   Time frame: Baseline and Week 52

4. Change From Baseline in Fasting Plasma Glucose (FPG) at 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.

   Time frame: Baseline and Week 156

5. Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at 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.

   Time frame: Week 52

6. Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at 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.

   Time frame: Week 156

7. Change From Baseline in Body Weight at 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.

   Time frame: Baseline and Week 52

8. Change From Baseline in Body Weight at 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.

   Time frame: Baseline and Week 156

Baseline characteristics

Publications

• Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15. PubMed 28683300 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.