An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Metformin XR; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643851

MB102-021

Details and patient eligibility

About

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

Enrollment: 994 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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994 participants in 3 patient groups

Arm 1

Experimental group

Description:

Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)

Treatment:

Drug: Dapagliflozin

Drug: Metformin XR

Arm 2

Experimental group

Description:

Dapagliflozin (5 mg)

Treatment:

Drug: Dapagliflozin

Arm 3

Active Comparator group

Description:

Metformin XR (500 mg up to 2000 mg)

Treatment:

Drug: Metformin XR