At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 570 enrolled
Drug / intervention
Saxagliptin +2 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 International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Placebo, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 570 participants across 30 sites in 3 countries.
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 patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesChina, India, South Korea
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartJun 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedApr 18, 2008
Enrollment StartJun 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.2 years ago
Interventions
Saxagliptindrug
Oral tablet, once daily for 24 weeks
Placebodrug
oral tablet, once daily for 24 weeks
Metformindrug
oral tablet, once daily for 24 weeks