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A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00263276
First received: December 7, 2005
Last updated: December 15, 2010
Last verified: December 2010
History of Changes
  Purpose

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied


Condition Intervention Phase
Type 2 Diabetes
 Drug: dapagliflozin
Drug: placebo
Drug: metformin
 Phase 2

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 Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Mean change from baseline in HbA1c compared to placebo. [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion [ Time Frame: at Weeks 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: December 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: dapagliflozin
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Experimental: Arm 2 Drug: dapagliflozin
Tablets, Oral, 5 mg, Once daily, 12 weeks.
Experimental: Arm 3 Drug: dapagliflozin
Tablets, Oral, 10 mg, Once daily, 12 weeks.
Experimental: Arm 4 Drug: dapagliflozin
Tablets, Oral, 20 mg, Once daily, 12 weeks.
Experimental: Arm 5 Drug: dapagliflozin
Tablets, Oral, 50 mg, Once daily, 12 weeks.
Placebo Comparator: Arm 6 Drug: placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks.
Active Comparator: Arm 7 Drug: metformin
Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. HbA1c >= 7% and <=10%.
  • Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.
  • C-peptide > 1.0 ng/ml
  • Body Mass Index <= 40 kg/m2
  • Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.
  • No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

Exclusion Criteria:

  • Unstable renal disease
  • Patients with significant liver disease including chronic active hepatitis
  • Within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable CHF,NYHA Class III or IV CHF, TIA, unstable arrhythmia or cardiac revascularization surgery.
  • Subjects with clinically significant anemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263276

  Show 144 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 by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol Myers Squibb
ClinicalTrials.gov Identifier: NCT00263276     History of Changes
Other Study ID Numbers: MB102-008
Study First Received: December 7, 2005
Last Updated: December 15, 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
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013