At a glance
ClinicalIndex Comparison Record- ✓Age 18–77 years
- ✓Type 2 diabetes with inadequate glycemic control: HbA1c 7–10% (Group 1) or 10.1–12% (Group 2)
- ✓Drug naïve or <24 weeks of prior diabetes medications
- ✓C-peptide ≥1.0 ng/mL at enrollment
- ✕Urine albumin-to-creatinine ratio >1,800 mg/g
- ✕Serum creatinine ≥1.5 mg/dL (men) or ≥1.4 mg/dL (women)
- ✕Hemoglobin <11 g/dL (men) or <10 g/dL (women)
- ✕History of diabetic ketoacidosis or hyperosmolar nonketotic coma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 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 Dapagliflozin, Dapagliflozin placebo, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 1,067 participants across 78 sites in 4 countries.
Detailed Summary
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this treatment will also be studied.
Study Details
Timeline
Interventions
Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks
Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks