Phase 3
Completed N=745
A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00838916 ↗Enrolled (actual)
745
Serious AEs
18.5%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 — -0.67; -0.79 Percentage of HbA1c in the blood — p=0.0086
Summary
A study 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 |
-0.67; -0.79 | 0.0086 sig |
| SECONDARY Change From Baseline in HbA1c at Week 156 |
-0.83; -1.00 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
-0.87; -2.06 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 |
-0.83; -2.19 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 |
54; 25; 156; 78; 268; 135 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 |
33; 18; 59; 46; 85; 71 | — |
| SECONDARY Time to Hyperglycemia Rescue |
107.57; NA | — |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
-1.05; 1.56 | — |
| SECONDARY Change From Baseline in Body Weight at Week 156 |
-3.47; 0.90 | — |
| SECONDARY Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52 |
0.457; -1.657 | — |
| SECONDARY Albiglutide Plasma Concentrations at Week 8 and Week 24 |
1642.83; 1911.35; 2159.30; 2748.15 | — |
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
Exclusion Criteria
- females who are pregnant, lactating or within <6 weeks post-partum
- current symptomatic heart failure (NYHA Class III-IV)
Data sourced from ClinicalTrials.gov (NCT00838916). 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.