Study identifier:MB102-029
ClinicalTrials.gov identifier:NCT00663260
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
Diabetes Mellitus, Type 2
Phase 2/3
No
Dapagliflozin, Placebo
All
631
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Dec 2016 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Bristol-Myers Squibb
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial
Location
Location
Greenbrae, CA, United States, 94904
Location
Los Gatos, CA, United States, 95032
Location
Charleston, SC, United States, 29406
Location
Myrtle Beach, SC, United States, 29572
Location
Tacoma, WA, United States, 98405
Location
Milwaukee, WI, United States, 53209
Location
Riverside, CA, United States, 92505
Location
Brooklyn Center, MN, United States, 55430
Arms | Assigned Interventions |
---|---|
Active Comparator: Dapagliflozin (10 mg) | Drug: Dapagliflozin Tablets, Oral, 10 mg, Once Daily, 104 weeks Other Name: BMS-512148 |
Active Comparator: Dapagliflozin (5 mg) | Drug: Dapagliflozin Tablets, Oral, 5 mg, Once Daily, 104 weeks Other Name: BMS-512148 |
Placebo Comparator: Placebo | Drug: Placebo Tablets, Oral, 0 mg, Once Daily, 104 weeks |
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