Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full description
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
- Clinical diagnosis of moderate renal impairment
Exclusion criteria
- AST and /or ALT > 3.0 times the upper limit of normal
- Serum total bilirubin > 1.5 times ULN
- Symptoms of severely uncontrolled diabetes
- Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Trial design
Primary purpose
Allocation
Interventional model
Masking
631 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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