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

NCT01095666 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1484

Last updated 2017-09-11

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Dapagliflozin

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

DRUG

Dapagliflozin

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

DRUG

Metformin

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

DRUG

Dapagliflozin Placebo

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

DRUG

Pioglitazone

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

Sponsors & Collaborators

  • AstraZeneca, Bristol-Myers Squibb

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • China
  • India
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095666 on ClinicalTrials.gov