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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00263276

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 II

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

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 ]

Estimated Enrollment:	385
Study Start Date:	December 2005
Study Completion Date:	February 2007

Arms	Assigned Interventions
Arm 1: Experimental	Drug: dapagliflozin Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Arm 2: Experimental	Drug: dapagliflozin Tablets, Oral, 5 mg, Once daily, 12 weeks.
Arm 3: Experimental	Drug: dapagliflozin Tablets, Oral, 10 mg, Once daily, 12 weeks.
Arm 4: Experimental	Drug: dapagliflozin Tablets, Oral, 20 mg, Once daily, 12 weeks.
Arm 5: Experimental	Drug: dapagliflozin Tablets, Oral, 50 mg, Once daily, 12 weeks.
Arm 6: Placebo Comparator	Drug: placebo Tablets, Oral, 0 mg, Once daily, 12 weeks.
Arm 7: Active Comparator	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 (micoralbumin/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 159 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More 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

Study ID Numbers:	MB102-008
Study First Received:	December 7, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00263276
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009