At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 891 enrolled
Drug / intervention
Metformin +2 moredrug
Likely dose
Sulphonylurea 20 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 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
In Brief
A Phase 3 clinical trial evaluating Metformin, Sulphonylurea, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 891 participants across 94 sites in 11 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 sulphonylurea in addition with metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesFinland, Germany, Hungary, India, Netherlands, Norway, Russia, Slovakia, South Korea, United Kingdom, Vietnam
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedDec 2007
Primary CompletionAug 2009
Study CompletionAug 2010
TodayJul 2026
First PostedDec 18, 2007
Enrollment StartDec 1, 2007
Primary CompletionAug 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.5 years ago
Interventions
Metformindrug
open-label metformin
Sulphonylureadrug
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Saxagliptindrug
Saxagliptin 5 mg tablets