A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01095653

MB102-054

Details and patient eligibility

About

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

Enrollment: 1,179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 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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1,179 participants in 3 patient groups

Group 1

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin Placebo

Drug: Metformin

Drug: Dapagliflozin

Group 2

Experimental group

Treatment:

Drug: Dapagliflozin

Drug: Dapagliflozin Placebo

Drug: Metformin

Drug: Dapagliflozin

Group 3

Experimental group

Treatment:

Drug: Dapagliflozin Placebo

Drug: Metformin