At a glance
ClinicalIndex Comparison Record- ✓Treatment naive males and females aged 18-77 years with type 2 diabetes mellitus
- ✓Central laboratory hemoglobin A1C between 7.5% and 12.0%
- ✓C-peptide ≥1.0 ng/mL (0.34 nmol/L)
- ✓Body Mass Index ≤45 kg/m²
- ✕Serum creatinine ≥1.50 mg/dL for males or ≥1.40 mg/dL for females
- ✕AST and/or ALT >3× upper limit of normal
- ✕Serum total bilirubin >2 mg/dL
- ✕Creatinine kinase >3× upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin, Metformin XR, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 1,093 participants across 123 sites in 6 countries.
Detailed Summary
The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with Dapagliflozin monotherapy, after 24 weeks of oral administration of double-blind treatment. The safety of treatment with dapagliflozin will also be assessed in this study
Study Details
Timeline
Interventions
Tablets, Oral, 10 mg, once daily, 24 weeks
Tablets, Oral, up to 2000 mg, once daily, 24 weeks
Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Tablets
Tablets