Phase 3
Completed N=301
Safety and Efficacy Study of Albiglutide in Type 2 Diabetes
Source: ClinicalTrials.gov NCT00849017 ↗Enrolled (actual)
301
Serious AEs
15.0%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 — 0.15; -0.70; -0.89 Percentage of HbA1c in the blood — p=<0.0001
Summary
The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 |
0.15; -0.70; -0.89 | <0.0001 sig |
| SECONDARY Change From Baseline in HbA1c at Weeks 104 and 156 |
-0.40; -0.93; -1.18; -0.61; -0.96; -1.07 | — |
| SECONDARY Time to Hyperglycemia Rescue |
49.71; 118.43; NA | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 |
1.00; -0.88; -1.38 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 |
-0.23; -1.31; -1.83 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 |
10; 25; 24; 21; 49; 39 | — |
| SECONDARY Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 |
6; 10; 11; 8; 18; 19 | — |
| SECONDARY Change From Baseline in Body Weight at Week 52 |
-0.66; -0.39; -0.86 | — |
| SECONDARY Change From Baseline in Body Weight at Week 156 |
-2.91; -1.32; -2.24 | — |
| SECONDARY Change From Baseline in Postprandial Blood Glucose Profile Parameter-4 Hour C-peptide AUC |
0.05; 0.03; 0.08 | — |
| SECONDARY Change From Baseline in Postprandial Blood Glucose Profile Parameter- 4 Hour Blood Glucose AUC |
-0.51; -1.74; -2.05 | — |
| SECONDARY Change From Baseline in Postprandial Blood Glucose Profile Parameters-4 Hour Insulin AUC and 4 Hour Proinsulin AUC |
49.2; 2.9; 39.9; 1.0; 1.9; -10.7 | — |
| SECONDARY Albiglutide Plasma Concentration at Weeks 8 and 24 |
1582; 1433; 1900; 1759; 1912; 3060 | — |
Eligibility Criteria
Inclusion Criteria
- type 2 diabetes
- BMI 20-45kg/m2 inclusive
Exclusion Criteria
- females who are pregnant, lactating, or <6 weeks post-partum
- CHF NYHA class III-IV
Data sourced from ClinicalTrials.gov (NCT00849017). 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.