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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- AstraZeneca
- Enrollment
- 631
- Locations
- 35
- Primary Endpoint
- Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
Detailed 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
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
Intervention: Placebo
Dapagliflozin (10 mg)
Intervention: Dapagliflozin
Dapagliflozin (5 mg)
Intervention: Dapagliflozin
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
Time Frame: From Baseline to Week 24
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.
Secondary Outcomes
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)