Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01046422
First received: January 11, 2010
Last updated: March 23, 2011
Last verified: September 2010
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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 | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent |
Drug: BMS-770767 Drug: Placebo Drug: Metformin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Fasting Plasma Glucose Improvement [ Time Frame: Within seven days following dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean daily glucose (3-day 7 pt-fingerstick) [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
- Four (4)-hour post-prandial glucose AUC [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
- HbA1C [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
- Lipid profiles [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
| Enrollment: | 76 |
| Study Start Date: | May 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BMS-770767 ± metformin (Treatment A) |
Drug: BMS-770767
Capsule, Oral, 15mg, Active, Daily, 28 days
Drug: Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
|
| Experimental: BMS-770767 ± metformin (Treatment B) |
Drug: BMS-770767
Capsule, Oral, 50mg, Active, Daily, 28 days
Drug: Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
|
| Experimental: BMS-770767 ± metformin (Treatment C) |
Drug: BMS-770767
Capsule, Oral, 150mg, Active, Daily, 28 days
Drug: Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
|
| Experimental: BMS-770767 ± metformin (Treatment D) |
Drug: BMS-770767
Capsule, Oral, 50mg BID, Active, Daily, 28 days
Drug: Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
|
| Placebo Comparator: Placebo ± metformin (Treatment E) |
Drug: Placebo
Capsule, Oral, 0mg, Daily, 28 days
Drug: Metformin
Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046422
Locations
| United States, California | |
| Marina Raikhel, Md | |
| Lomita, California, United States, 90717 | |
| United States, Nevada | |
| Nevada Alliance Against Diabetes | |
| Las Vegas, Nevada, United States, 89101 | |
| Australia, Queensland | |
| Local Institution | |
| Caboolture, Queensland, Australia, 4510 | |
| Local Institution | |
| Meadowbrook, Queensland, Australia, 4131 | |
| Australia, South Australia | |
| Local Institution | |
| Daw Park, South Australia, Australia, 5041 | |
| Australia, Victoria | |
| Local Institution | |
| Geelong, Victoria, Australia, 3220 | |
| Australia, Western Australia | |
| Local Institution | |
| Nedlands, Western Australia, Australia, 6009 | |
| Canada, Manitoba | |
| Local Institution | |
| Winnipeg, Manitoba, Canada, R3P 1R9 | |
| Canada, Newfoundland and Labrador | |
| Local Institution | |
| Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7 | |
| Canada, Ontario | |
| Local Institution | |
| Brampton, Ontario, Canada, L6T 3J1 | |
| Local Institution | |
| Toronto, Ontario, Canada, M4G 3E8 | |
| Canada, Prince Edward Island | |
| Local Institution | |
| Charlottetown, Prince Edward Island, Canada, C1A 5Y9 | |
| Canada, Quebec | |
| 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 | |
| Korea, Republic of | |
| Local Institution | |
| Incheon, Korea, Republic of, 405-760 | |
| Local Institution | |
| Suwon, Korea, Republic of, 443-721 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01046422 History of Changes |
| Other Study ID Numbers: | MB117-003, 2009-014308-79 |
| Study First Received: | January 11, 2010 |
| Last Updated: | March 23, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Korea: Food and Drug Administration United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013