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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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Dapagliflozin
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 67
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
20 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
Experimental: Cohort 2 - Arm 1
10 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
Experimental: Cohort 2 - Arm 2
20 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
Placebo Comparator: Cohort 2 - Arm 3 Drug: Placebo
Tablets, Oral, 0 mg, once daily, up to 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357370

  Show 23 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00357370     History of Changes
Other Study ID Numbers: MB102-009
Study First Received: July 26, 2006
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013