Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
Summary
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.
Timeline
- Start
- 2007-04
- Primary completion
- 2008-05
- Completion
- 2008-05
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Albiglutide 30 mg Weekly; p = 0.0027; Mean Difference (Final Values) -0.62 (95% CI -1.03 to -0.22); ANCOVA NCT00518115 ↗
registry analysis (superiority or other test); Placebo vs Albiglutide 100 mg Every 4 Weeks; p = 0.0022; Mean Difference (Final Values) -0.60 (95% CI -0.99 to -0.22); ANCOVA NCT00518115 ↗
Publications
- Background Rosenstock J, Reusch J, Bush M, Yang F, Stewart M; Albiglutide Study Group. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009 Oct;32(10):1880-6. doi: 10.2337/dc09-0366. Epub 2009 Jul 10.
- Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | — | — |
| Subject | albiglutide | Peptide | — | Subcutaneous |