A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00357370

First received: July 26, 2006

Last updated: September 10, 2010

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 26, 2006

Last Updated Date

September 10, 2010

Start Date ^ICMJE

October 2006

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Change from baseline in hemoglobin A1C [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in hemoglobin A1C at Week 12

Change History

Complete list of historical versions of study NCT00357370 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in fasting plasma glucose [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
Change from baseline in the proportion of subjects achieving therapeutic glycemic responses [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
Change from baseline in the total daily dose of insulin [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change from baseline in fasting plasma glucose at Week 12
Change from baseline in the proportion of subjects achieving therapeutic glycemic responses
Change from baseline in the total daily dose of insulin

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

Official Title ^ICMJE

A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin.

Brief Summary

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
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 12 weeks

Other Name: BMS-512148
Drug: Placebo
Tablets, Oral, 0 mg, once daily, up to 12 weeks

Study Arm (s)

Experimental: Cohort 1
20 mg

Intervention: Drug: Dapagliflozin
Experimental: Cohort 2 - Arm 1
10 mg

Intervention: Drug: Dapagliflozin
Experimental: Cohort 2 - Arm 2
20 mg

Intervention: Drug: Dapagliflozin
Placebo Comparator: Cohort 2 - Arm 3
Intervention: Drug: 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

Completion Date

March 2008

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
Subjects receiving insulin and metformin and/or a thiazolidinedione
Body Mass Index <=45.0 kg/m2
Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)

Exclusion Criteria:

History of type 1 diabetes
AST and/or ALT >2.5 times the upper limit of normal
Creatinine kinase ≥3 times the upper limit of normal
Symptoms of severely uncontrolled diabetes
History of hypoglycemic unawareness
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00357370

Other Study ID Numbers ^ICMJE

MB102-009

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

July 2009

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

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