A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
Overview
- Phase
- Phase 3
- Intervention
- Dapagliflozin
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 972
- Locations
- 58
- 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 clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, ≥ 18 years old, with type 2 diabetes and with inadequate glycemic control
- •All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
- •C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- •Body Mass Index ≤ 45.0 kg/m²
Exclusion Criteria
- •AST and /or ALT \> 2.5 times the upper limit of normal
- •Serum total bilirubin \> 2 mg/dL (34.2 µmol/L)
- •Creatinine kinase \> 3.0 times the upper limit of normal
- •Symptoms of severely uncontrolled diabetes
- •Serum creatinine ≥ 2.0 mg/dL
- •Calculated Cr-Clearance \< 50 ml/min (calculated by Cockroft-Gault formula)
- •Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Arms & Interventions
Arm 1
Intervention: Dapagliflozin
Arm 1
Intervention: Thiazolidinedione (Pioglitazone)
Arm 2
Intervention: Dapagliflozin
Arm 2
Intervention: Thiazolidinedione (Pioglitazone)
Arm 3
Intervention: Placebo matching Dapagliflozin
Arm 3
Intervention: Thiazolidinedione (Pioglitazone)
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, 8, 12, 16, 20, and 24 in the double-blind period.
Secondary Outcomes
- Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 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)
- Adjusted Mean Change From Baseline in Waist Circumference (cm) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)