A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Overview
- Phase
- Phase 3
- Intervention
- Dapagliflozin
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 994
- Locations
- 45
- Primary Endpoint
- Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males \& females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
- •Drug naive or treated with anti-diabetic medication for \< 24 weeks since original diagnosis
- •C-peptide ≥ 1.0 ng/mL
- •Body Mass Index ≤ 45.0 kg/m
- •Serum creatinine \< 1.50 mg/dL for men or \< 1.40 mg/dL for women
Exclusion Criteria
- •AST and/or ALT \>3.0 times the upper limit of normal (ULN)
- •Serum total bilirubin \> 2.0 mg/dL
- •Creatine kinase \> 3X the upper limit of normal (ULN)
- •Symptoms of severely uncontrolled diabetes
- •Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
Arms & Interventions
Arm 1
Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
Intervention: Dapagliflozin
Arm 1
Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
Intervention: Metformin XR
Arm 2
Dapagliflozin (5 mg)
Intervention: Dapagliflozin
Arm 3
Metformin XR (500 mg up to 2000 mg)
Intervention: Metformin XR
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
- Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)
- 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 Hemoglobin A1C (HbA1c) in Subjects With Baseline HbA1c ≥ 9% 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 Total Body Weight (kg) in Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF])(From Baseline to Week 24)