At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 93 enrolled
Drug / intervention
Saxagliptin +1 moredrug
Likely dose
Saxagliptin 5mgfrom 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 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate The Efficacy And Safety Of Saxagliptin In Comparison To Placebo As Add On Treatment To Metformin XR In Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet And Exercise And A Stable Dose Of Metformin ≥1500 mg/Day
In Brief
A Phase 3 clinical trial evaluating Saxagliptin and Placebo for Type 2 Diabetes. Completed, enrolled 93 participants across 27 sites in 8 countries.
Detailed Summary
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesArgentina, Israel, Italy, Mexico, Philippines, Puerto Rico, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2008
Enrollment StartJul 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedMay 23, 2008
Enrollment StartJul 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.1 years ago
Interventions
Saxagliptindrug
Tablets, Oral, 5mg, once daily, 4 weeks
Placebodrug
Tablets, Oral, 0 mg, once daily, 4 weeks