Phase 3
Completed N=301
Safety and Efficacy of Albiglutide in Type 2 Diabetes
Source: ClinicalTrials.gov NCT00849056 ↗Enrolled (actual)
301
Serious AEs
14.3%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 — -0.05; -0.81 Percentage of HbA1c in the blood — p=<0.0001
Summary
The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 |
-0.05; -0.81 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c at Weeks 104 and 156 |
-0.72; -0.92; -0.50; -0.87 | — |
| SECONDARY Time to Hyperglycemia Rescue |
52.86; NA | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
0.35; -1.28 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 |
0.03; -1.26 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 |
8; 37; 22; 66; 44; 96 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 |
7; 20; 12; 32; 17; 44 | — |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
0.45; 0.28 | — |
| SECONDARY Change From Baseline in Body Weight at Week 156 |
1.50; -0.16 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00849056). 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.