At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 213 enrolled
Drug / intervention
Saxagliptin +1 moredrug
Likely dose
Not stated in 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 24-Week National, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase IIIb Study in India to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise
In Brief
A Phase 3 clinical trial evaluating Saxagliptin and Placebo for Type 2 Diabetes. Completed, enrolled 213 participants across 9 sites.
Detailed Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients with inadequate glycaemic control with diet and exercise.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesIndia
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedJun 2009
Primary CompletionJul 2010
TodayJul 2026
First PostedJun 11, 2009
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.1 years ago
Interventions
Saxagliptindrug
Oral tablet, once daily for 24 weeks
Placebodrug
Oral tablet, once daily for 24 weeks