At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 257 enrolled
Drug / intervention
Saxagliptin +1 moredrug
Likely dose
Saxagliptin 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 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin and Sulfonylurea in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Combination of Metformin and Sulfonylurea
In Brief
A Phase 3 clinical trial evaluating Saxagliptin and Placebo for Type 2 Diabetes. Completed, enrolled 257 participants across 33 sites in 6 countries.
Detailed Summary
The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesAustralia, Canada, India, South Korea, Thailand, United Kingdom
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2010
Enrollment StartJun 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedMay 21, 2010
Enrollment StartJun 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.1 years ago
Interventions
Saxagliptindrug
5 mg tablet once daily for 24 weeks to be taken orally
Placebodrug
tablet once daily for 24 weeks to be taken orally