A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00263276 |
Recruitment Status
:
Completed
First Posted
: December 8, 2005
Last Update Posted
: November 17, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: dapagliflozin Drug: placebo Drug: metformin | Phase 2 |
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 |

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.
|
- Mean change from baseline in HbA1c compared to placebo. [ Time Frame: at 12 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Senior) |
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

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

Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00263276 History of Changes |
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:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |