At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus
- ✓Drug naive (no prior diabetes medications)
- ✓HbA1c between 7.0% and 10.0% (7.0%-12.0% for open-label arm)
- ✓Fasting C-peptide ≥1 ng/mL (evidence of residual beta cell function)
- ✕Symptomatic poorly controlled diabetes
- ✕Recent cardiac or cerebrovascular event
- ✕Serum creatinine ≥1.5 mg/dL in males or ≥1.4 mg/dL in women of childbearing potential
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Placebo matching Saxagliptin, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 1,035 participants across 134 sites in 6 countries.
Detailed Summary
The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise
Study Details
Timeline
Interventions
Tablets, Oral, 2.5 mg, Once daily (24 weeks short term \[ST\], 42 months long term \[LT\])
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)
Tablets, Oral, 500 mg, daily (42 months LT)
Tablets, Oral, 0 mg, daily (42 months LT)
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label
Tablets, Oral, 500-2000 mg (as needed for rescue)