At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,306 enrolled
Drug / intervention
Saxagliptin +4 moredrug
Likely dose
Saxagliptin 10 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 Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Metformin, and 2 other interventions for Diabetes. Completed, enrolled 1,306 participants across 211 sites in 13 countries.
Detailed Summary
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesArgentina, Brazil, Germany, Hungary, India, Italy, Mexico, Philippines, Poland, Puerto Rico, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedMay 2006
Primary CompletionNov 2007
Study CompletionDec 2008
TodayJul 2026
First PostedMay 17, 2006
Enrollment StartMay 1, 2006
Primary CompletionNov 1, 2007
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.1 years ago
Interventions
Saxagliptindrug
Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
Saxagliptindrug
Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
Metformindrug
Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
Placebodrug
Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
pioglitazonedrug
Tablets, Oral, 15-45 mg, as needed (12 months LT)