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

Study identifier:MB102-054

ClinicalTrials.gov identifier:NCT01095653

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control with Diet and Exercise

Medical condition

Type 2 Diabetes

Phase

Phase 3

Healthy volunteers

Study drug

Dapagliflozin, Metformin, Dapagliflozin Placebo

Sex

All

Actual Enrollment

1179

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2010

Primary Completion Date: 01 Mar 2012

Study Completion Date: 01 Mar 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca Pharmaceuticals

Collaborators

AstraZeneca, Bristol-Myers Squibb

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Group 1	Drug: Dapagliflozin Tablets, Oral, 5 mg, Once daily, 24 weeks Other Name: BMS-512148 Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks Other Name: Glucophage® Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks
Experimental: Group 2	Drug: Dapagliflozin Tablets, Oral, 10 mg, Once daily, 24 weeks Other Name: BMS-512148 Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks Other Name: Glucophage® Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks
Experimental: Group 3	Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks Other Name: Glucophage® Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
Publication
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

First line of email MUST contain NCT# & Site#. Only trial are recruiting have contact information at this time.

Investigators

Principal Investigator

Bristol-Myers Squibb