Safety Study of BMS-823778 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 assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).

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-823778 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 Mellitus, Type 2

Intervention / Treatment
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* Drug: BMS-823778
* Drug: BMS-823778
* Drug: BMS-823778
* Drug: Placebo
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus Drug naive or on stable metformin therapy HbA1c 7-10% FPG ≤ 240mg/dL Exclusion Criteria: History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study Congestive heart failure Active liver disease Impaired renal function Hepatitis C, B and HIV This list is not inclusive; additional information is provided in the protocol

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 |
| --- | --- |
| Active Comparator: BMS-823778 (2 mg)<br>+ metformin | Drug: BMS-823778<br>* Capsules, Oral, 2 mg, once daily, 28 days<br>Drug: Metformin<br>* Capsules, Oral, ≥ 1500 mg, once daily, 28 days<br>|
| Active Comparator: BMS-823778 (10 mg)<br>+ metformin | Drug: BMS-823778<br>* Capsules, Oral, 10 mg, once daily, 28 days<br>Drug: Metformin<br>* Capsules, Oral, ≥ 1500 mg, once daily, 28 days<br>|
| Active Comparator: BMS-823778 (20 mg)<br>+ metformin | Drug: BMS-823778<br>* Capsules, Oral, 20 mg, once daily, 28 days<br>Drug: Metformin<br>* Capsules, Oral, ≥ 1500 mg, once daily, 28 days<br>|
| Placebo Comparator: Placebo<br>+ metformin | Drug: Placebo<br>* Capsules, Oral, 0 mg, once daily, 28 days<br>Drug: Metformin<br>* Capsules, Oral, ≥ 1500 mg, once daily, 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline |  | Within 28 days following dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (measuring trough concentrations) |  | On days 7, 14 and 28 | 
| Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG) |  | Within 28 days following dosing |