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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00263276
Recruitment Status : Completed
First Posted : December 8, 2005
Last Update Posted : November 17, 2016
Bristol-Myers Squibb
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: dapagliflozin Drug: placebo Drug: metformin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Mean change from baseline in HbA1c compared to placebo. [ Time Frame: at 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263276

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00263276    
Other Study ID Numbers: MB102-008
First Posted: December 8, 2005    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action