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

This study has been completed.

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01095653

First received: March 26, 2010

Last updated: March 28, 2013

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2010

Last Updated Date

March 28, 2013

Start Date ^ICMJE

June 2010

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in HbA1c for each dose of dapagliflozin vs placebo [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01095653 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in Fasting Plasma Glucose (FPG) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Change from baseline in 2hr-post meal glucose [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0% [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Change from baseline in total body weight [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once daily, 24 weeks

Other Name: BMS-512148
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

Study Arm (s)

Experimental: Group 1
Interventions:
- Drug: Dapagliflozin
- Drug: Metformin
- Drug: Dapagliflozin Placebo
Experimental: Group 2
Interventions:
- Drug: Dapagliflozin
- Drug: Metformin
- Drug: Dapagliflozin Placebo
Experimental: Group 3
Interventions:
- Drug: Metformin
- Drug: Dapagliflozin Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

393

Completion Date

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China, India

Administrative Information

NCT Number ^ICMJE

NCT01095653

Other Study ID Numbers ^ICMJE

MB102-054

Has Data Monitoring Committee

Yes

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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