Phase 3
Completed N=1,012
Efficacy and Safety of Albiglutide in Treatment of Type 2 Diabetes
Source: ClinicalTrials.gov NCT00838903 ↗Enrolled (actual)
1,012
Serious AEs
12.6%
Results posted
May 2014
Primary outcomePrimary: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 — 0.27; -0.28; -0.36; -0.63 Percentage of HbA1c in the blood — p=<0.0001
Summary
The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 |
0.27; -0.28; -0.36; -0.63 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c at Week 156 |
-0.46; -0.56; -0.59; -0.88 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 |
0.55; -0.12; -0.41; -0.98 | — |
| SECONDARY Change From Baseline in FPG at Week 156 |
-0.11; -0.50; -0.71; -1.30 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104 |
7; 45; 40; 50; 15; 94 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 |
4; 23; 15; 31; 7; 44 | — |
| SECONDARY Time to Hyperglycemia Rescue |
67.71; NA; NA; NA | — |
| SECONDARY Change From Baseline in Body Weight at Week 104 |
-1.00; -0.86; 1.17; -1.21 | — |
| SECONDARY Change From Baseline in Body Weight at Week 156 |
-3.61; -2.05; 0.98; -2.31 | — |
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
Exclusion Criteria
- females who are pregnant, lactating or <6 weeks post-partum
- current symptomatic heart failure (NYHA Class III or IV)
Data sourced from ClinicalTrials.gov (NCT00838903). 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.