At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus on metformin monotherapy at dose ≥1500 mg and ≤2550 mg for ≥8 weeks before screening
- ✓HbA1c between 7.0% and 10.0%
- ✓Body mass index ≤40 kg/m²
- ✓Fasting C-peptide ≥1 ng/dL
- ✕Symptomatic poorly controlled diabetes
- ✕Recent cardiac or cerebrovascular event
- ✕Serum creatinine ≥1.5 mg/dL in males or ≥1.4 mg/dL in females
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"
In Brief
A Phase 3 clinical trial evaluating Saxagliptin + Metformin, Placebo + Metformin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 1,462 participants across 152 sites in 9 countries.
Detailed Summary
The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone
Study Details
Timeline
Interventions
Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 15 - 45 mg (as needed for rescue)