Phase 3
Completed N=663
A Study to Determine the Safety and Efficacy of Albiglutide in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00839527 ↗Enrolled (actual)
663
Serious AEs
16.3%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 — 0.33; -0.80; -0.55 Percentage of HbA1c in the blood — p=<0.0001
Summary
The purpose of this study is to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 |
0.33; -0.80; -0.55 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c at Week 104 and Week 156 |
-0.32; -1.09; -0.76; -0.10; -0.97; -0.46 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
0.64; -1.74; -0.69 | — |
| SECONDARY Change From Baseline in FPG at Week 104 and Week 156 |
0.43; -1.98; -0.99; -0.50; -1.94; -0.88 | — |
| SECONDARY Time to Hyperglycemia Rescue |
49.57; NA; 137.71 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 |
4; 37; 27; 10; 94; 79 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 |
1; 23; 16; 3; 44; 26 | — |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
-0.40; 4.43; -0.42 | — |
| SECONDARY Change From Baseline in Body Weight at Week 104 and Week 156 |
-2.16; 6.28; -0.90; -4.47; 6.52; -1.53 | — |
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
Exclusion Criteria
- females who are pregnant, lactating, or less than 6 weeks post-partum
- current symptomatic heart failure (NYHA Class II-IV)
Data sourced from ClinicalTrials.gov (NCT00839527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.