Safety Study of BMS-770767 in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to determine if BMS-770767 is safe, well tolerated, measure its levels in the blood (pharmacokinetics), and measure the levels of chemicals (biomarkers) that may be affected by this drug (pharmacodynamics) in a type 2 diabetes patient population

Official Title
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A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Drug: BMS-770767
* Drug: BMS-770767
* Drug: BMS-770767
* Drug: BMS-770767
* Drug: Placebo
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes with inadequate glycemic control and treated with either diet and exercise alone, or with stable doses (≥ 1500mg/d) of metformin for at least 8 weeks prior to screening HbA1c ≥ 7.0% and ≤ 10.0% with FPG ≤ 240mg/dL (13.3 mmol/dL) Exclusion Criteria: Women of childbearing potential History of diabetic ketoacidosis or hyperosmolar nonketotic coma Significant cardiovascular history History of unstable or rapidly progressing renal disease Impaired renal function defined by a serum creatinine > 1.4mg/dL (124 µmol/L) for women and >1.5mg/dL (133 µmol/L) for men Active liver disease and /or significant abnormal liver function defined as AST > 3X ULN and/or ALT > 3XULN and /or serum total bilirubin > 2.0mg/dl

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-770767 ± metformin (Treatment A)<br> | Drug: BMS-770767<br>* Capsule, Oral, 15mg, Active, Daily, 28 days<br>Drug: Metformin<br>* Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days<br>|
| Experimental: BMS-770767 ± metformin (Treatment B)<br> | Drug: BMS-770767<br>* Capsule, Oral, 50mg, Active, Daily, 28 days<br>Drug: Metformin<br>* Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days<br>|
| Experimental: BMS-770767 ± metformin (Treatment C)<br> | Drug: BMS-770767<br>* Capsule, Oral, 150mg, Active, Daily, 28 days<br>Drug: Metformin<br>* Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days<br>|
| Experimental: BMS-770767 ± metformin (Treatment D)<br> | Drug: BMS-770767<br>* Capsule, Oral, 50mg BID, Active, Daily, 28 days<br>Drug: Metformin<br>* Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days<br>|
| Placebo Comparator: Placebo ± metformin (Treatment E)<br> | Drug: Placebo<br>* Capsule, Oral, 0mg, Daily, 28 days<br>Drug: Metformin<br>* Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose Improvement |  | Within seven days following dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean daily glucose (3-day 7 pt-fingerstick) |  | Within 28 days following dosing | 
| Four (4)-hour post-prandial glucose AUC |  | Within 28 days following dosing | 
| HbA1C |  | Within 28 days following dosing | 
| Lipid profiles |  | Within 28 days following dosing |