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
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
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
Inclusion Criteria:
Exclusion Criteria:
Voorhees Township, New Jersey 08043, United States
Buenos Aires, Buenos Aires C1012AAR, Argentina
Buenos Aires, Buenos Aires C1408INH, Argentina
Capital Federal, Buenos Aires C1405BCJ, Argentina
Woollongong, New South Wales 2500, Australia
Copenhagen Nv, 2400, Denmark
Rajasthan, 302 001, India
Df, Mexico City 01120, Mexico
Df, Mexico City 06700, Mexico
Df, Mexico City 11800, Mexico
San Sebastian de Los, 28702, Spain
Vizcaya, 48903, Spain