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

This study has been completed.

Sponsor:

Collaborator:

AstraZeneca

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00528879

First received: September 11, 2007

Last updated: September 10, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 11, 2007

Last Updated Date

September 10, 2010

Start Date ^ICMJE

September 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in hemoglobin A1C [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in hemoglobin A1C [ Time Frame: at Week 24 ]

Change History

Complete list of historical versions of study NCT00528879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in fasting plasma glucose [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
Proportion of subjects achieving a therapeutic glycemic response, defined as AIC < 7.0% [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
Proportion of subjects achieving a therapeutic glycemic response, defined as AIC ≤ 6.5% [ 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 ]
Change from baseline in fasting plasma glucose [ Time Frame: at Week 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in fasting plasma glucose [ Time Frame: at Week 24 ]
Proportion of subjects achieving a therapeutic glycemic response, defined as AIC < 7.0% [ Time Frame: at Week 24 ]
Change from baseline in total body weight [ Time Frame: at Week 24 ]
Change from baseline in fasting plasma glucose [ Time Frame: at Week 1 ]

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 Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Brief Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on metformin alone. 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, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Dapagliflozin
Tablets, Oral, once daily, Up to 102 weeks

Other Name: BMS-512148
Drug: placebo
Tablets, Oral, once daily, Up to 102 weeks

Study Arm (s)

Experimental: Arm 1
2.5 mg

Intervention: Drug: Dapagliflozin
Experimental: Arm 2
5 mg

Intervention: Drug: Dapagliflozin
Experimental: Arm 3
10 mg

Intervention: Drug: Dapagliflozin
Placebo Comparator: Arm 4
0 mg

Intervention: Drug: placebo

Publications *

* 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

546

Completion Date

May 2010

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
Subjects who have been receiving metformin at a total daily dose ≥ 1500 mg/day for at least 8 weeks
C-peptide ≥ 1.0 ng/mL
Body Mass Index ≤ 45.0 kg/m2\
Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women.

Exclusion Criteria:

AST and /or ALT > 3.0 times the upper limit of normal
Serum total bilirubin > 2 mg/dL
Creatinine kinase > 3 times the upper limit of normal
Symptoms of severely uncontrolled diabetes
Serum creatinine ≥ 1.50 mg/dL (133 µmol/L) for men or ≥ 1.40 mg/dL for women (124 µmol/L)
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Gender

Both

Ages

18 Years to 77 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Canada, Mexico

Administrative Information

NCT Number ^ICMJE

NCT00528879

Other Study ID Numbers ^ICMJE

MB102-014

Has Data Monitoring Committee

Responsible Party

Study Director, 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

May 2010

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

To Top