At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 423 enrolled
Drug / intervention
Saxagliptin +6 moredrug
Likely dose
Saxagliptin 2.5 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 Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
In Brief
A Phase 2 clinical trial evaluating Saxagliptin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 423 participants.
Detailed Summary
To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2003
Primary CompletionMay 2004
First PostedAug 2009
TodayJul 2026
First PostedAug 3, 2009
Enrollment StartMay 1, 2003
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.9 years ago
Interventions
Saxagliptindrug
Tablets, Oral, 2.5 mg, once daily, 12 weeks
Saxagliptindrug
Tablets, Oral, 5 mg, once daily, 12 weeks
Saxagliptindrug
Tablets, Oral, 10 mg, once daily, 12 weeks
Saxagliptindrug
Tablets, Oral, 20 mg, once daily, 12 weeks
Saxagliptindrug
Tablets, Oral, 40 mg, once daily, 12 weeks
Saxagliptindrug
Tablets, Oral, 100 mg, once daily, 6 weeks
Placebodrug
Tablets, Oral, 0 mg, once daily, 6 and 12 weeks