Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | 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 |
|---|---|
| Condition | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: BMS-770767 Drug: BMS-770767 Drug: BMS-770767 Drug: BMS-770767 Drug: Placebo Drug: Metformin |
| Phase | Phase 2 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01046422 |
| First Received | January 11, 2010 |
| Last Updated | March 23, 2011 |
| Last verified | September 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 11, 2010 |
|---|---|
| Last Updated Date | March 23, 2011 |
| Start Date | May 2010 |
| Estimated Primary Completion Date | January 2011 |
| Current Primary Outcome Measures | Fasting Plasma Glucose Improvement [Time Frame: Within seven days following dosing] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Safety Study of BMS-770767 in Subjects With Type 2 Diabetes |
|---|---|
| Official Title | 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 |
| Brief Summary | 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Non-Insulin-Dependent |
| Intervention | Drug: BMS-770767 Capsule, Oral, 15mg, Active, Daily, 28 days Drug: BMS-770767 Capsule, Oral, 50mg, Active, Daily, 28 days Drug: BMS-770767 Capsule, Oral, 150mg, Active, Daily, 28 days Drug: BMS-770767 Capsule, Oral, 50mg BID, Active, Daily, 28 days Drug: Placebo Capsule, Oral, 0mg, Daily, 28 days Drug: Metformin Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 76 |
| Estimated Completion Date | January 2011 |
| Estimated Primary Completion Date | January 2011 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Australia, Canada, Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01046422 |
|---|---|
| Other Study ID Numbers | MB117-003 |
| Has Data Monitoring Committee | No |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | Not Provided |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | September 2010 |
Locations[ + expand ][ + ]
| Marina Raikhel, Md | Lomita, California, United States, 90717 |
|---|---|
| Nevada Alliance Against Diabetes | Las Vegas, Nevada, United States, 89101 |
| Local Institution | Caboolture, Queensland, Australia, 4510 |
| Local Institution | Meadowbrook, Queensland, Australia, 4131 |
| Local Institution | Daw Park, South Australia, Australia, 5041 |
| Local Institution | Geelong, Victoria, Australia, 3220 |
| Local Institution | Nedlands, Western Australia, Australia, 6009 |
| Local Institution | Winnipeg, Manitoba, Canada, R3P 1R9 |
| Local Institution | Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7 |
| Local Institution | Brampton, Ontario, Canada, L6T 3J1 |
| Local Institution | Toronto, Ontario, Canada, M4G 3E8 |
| Local Institution | Charlottetown, Prince Edward Island, Canada, C1A 5Y9 |
| Local Institution | Drummondville, Quebec, Canada, J2B 7T1 |
| Local Institution | Lachine, Quebec, Canada, H8S 2E4 |
| Local Institution | Laval, Quebec, Canada, H7T 2P5 |
| Local Institution | Montreal, Quebec, Canada, H3J 2V5 |
| Local Institution | Incheon, Korea, Republic of, 405-760 |
| Local Institution | Suwon, Korea, Republic of, 443-721 |