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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 5 mg, Once daily, 24 weeks

Metformin

Intervention Type DRUG

Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks

Dapagliflozin Placebo

Intervention Type DRUG

Tablets, Oral, 0 mg, Once daily, 24 weeks

Pioglitazone

Intervention Type DRUG

Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Group 2

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg, Once daily, 24 weeks

Metformin

Intervention Type DRUG

Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks

Dapagliflozin Placebo

Intervention Type DRUG

Tablets, Oral, 0 mg, Once daily, 24 weeks

Pioglitazone

Intervention Type DRUG

Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Group 3

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks

Dapagliflozin Placebo

Intervention Type DRUG

Tablets, Oral, 0 mg, Once daily, 24 weeks

Pioglitazone

Intervention Type DRUG

Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Interventions

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Dapagliflozin

Tablets, Oral, 5 mg, Once daily, 24 weeks

Intervention Type DRUG

Dapagliflozin

Tablets, Oral, 10 mg, Once daily, 24 weeks

Intervention Type DRUG

Metformin

Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks

Intervention Type DRUG

Dapagliflozin Placebo

Tablets, Oral, 0 mg, Once daily, 24 weeks

Intervention Type DRUG

Pioglitazone

Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

Intervention Type DRUG

Other Intervention Names

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BMS-512148 BMS-512148 Glucophage®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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