At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 286 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, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin
In Brief
A Phase 4 clinical trial evaluating Saxagliptin and Metformin for Type 2 Diabetes Mellitus. Completed, enrolled 286 participants across 51 sites in 7 countries.
Detailed Summary
The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesBelgium, France, Germany, Italy, Spain, Turkey (Türkiye), United Kingdom
CollaboratorsBristol-Myers Squibb
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedNov 2009
Study CompletionDec 2010
TodayJul 2026
First PostedNov 3, 2009
Enrollment StartOct 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Posted 16.7 years ago
Interventions
Saxagliptindrug
5 mg, oral tablet, once daily
Metformindrug
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy