At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 572 enrolled
Drug / intervention
Saxagliptin +1 moredrug
Likely dose
Saxagliptin 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin Compared With Placebo in Adult Patients With Type 2 Diabetes and Renal Impairment (Moderate, Severe, and End-Stage) With an Additional 40-week, Randomized, Double-blind, Placebo-controlled Long-term Observational Period.
In Brief
A Phase 3 clinical trial evaluating Saxagliptin and Placebo for Type 2 Diabetes. Completed, enrolled 572 participants across 74 sites in 14 countries.
Detailed Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesBelarus, Bulgaria, Croatia, Czechia, Estonia, Germany, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Ukraine, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedFeb 2008
Primary CompletionJun 2009
Study CompletionMar 2010
TodayJul 2026
First PostedFeb 13, 2008
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.4 years ago
Interventions
Saxagliptindrug
2.5 mg once daily oral dose
Placebodrug
Placebo