At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment
In Brief
A Phase 3 clinical trial evaluating albiglutide and sitagliptin for Diabetes Mellitus, Type 2. Completed, enrolled 507 participants across 218 sites in 15 countries.
Detailed Summary
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
Study Details
Timeline
Interventions
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)