At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 822 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.
18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone
In Brief
A Phase 3 clinical trial evaluating saxagliptin and sitagliptin for Type 2 Diabetes. Completed, enrolled 822 participants across 87 sites in 9 countries.
Detailed Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesArgentina, Belgium, Denmark, France, Italy, Mexico, Norway, South Africa, Sweden
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedApr 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedApr 25, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.2 years ago
Interventions
saxagliptindrug
tablet, per oral, once daily
sitagliptindrug
capsule, per oral, once daily