A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Dapagliflozin Placebo; Drug: Dapagliflozin; Drug: Metformin; Drug: Pioglitazone

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01095666

MB102-055

Details and patient eligibility

About

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

Enrollment: 1,484 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
• Drug naive or treated with anti-diabetic medication for < 24 weeks
• C-peptide ≥ 1.0 ng/mL
• Body Mass Index ≤ 45.0 kg/m²

Exclusion criteria

• AST and/or ALT > 3 times ULN
• Serum total bilirubin > 2 mg/dL
• Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
• Creatine kinase ≥ 3 times 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: Quadruple Blind

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1,484 participants in 3 patient groups

Group 1

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Pioglitazone

Drug: Metformin

Drug: Dapagliflozin Placebo

Drug: Dapagliflozin

Group 2

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Pioglitazone

Drug: Metformin

Drug: Dapagliflozin Placebo

Drug: Dapagliflozin

Group 3

Experimental group

Treatment:

Drug: Pioglitazone

Drug: Metformin

Drug: Dapagliflozin Placebo