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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: dapagliflozin
* Drug: dapagliflozin
* Drug: dapagliflozin
* Drug: dapagliflozin
* Drug: dapagliflozin
* Drug: placebo
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: dapagliflozin<br>* Tablets, Oral, 2.5 mg, Once daily, 12 weeks.<br>|
| Experimental: Arm 2<br> | Drug: dapagliflozin<br>* Tablets, Oral, 5 mg, Once daily, 12 weeks.<br>|
| Experimental: Arm 3<br> | Drug: dapagliflozin<br>* Tablets, Oral, 10 mg, Once daily, 12 weeks.<br>|
| Experimental: Arm 4<br> | Drug: dapagliflozin<br>* Tablets, Oral, 20 mg, Once daily, 12 weeks.<br>|
| Experimental: Arm 5<br> | Drug: dapagliflozin<br>* Tablets, Oral, 50 mg, Once daily, 12 weeks.<br>|
| Placebo Comparator: Arm 6<br> | Drug: placebo<br>* Tablets, Oral, 0 mg, Once daily, 12 weeks.<br>|
| Active Comparator: Arm 7<br> | Drug: metformin<br>* Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in HbA1c compared to placebo. |  | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | at Weeks 6 and 12 |