Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01111955
First received: April 26, 2010
Last updated: February 22, 2011
Last verified: February 2011
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Purpose
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: BMS-823778 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) 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-823778 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:
- Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics (measuring trough concentrations) [ Time Frame: On days 7, 14 and 28 ] [ Designated as safety issue: Yes ]
- Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG) [ Time Frame: Within 28 days following dosing ] [ Designated as safety issue: Yes ]
| Enrollment: | 62 |
| Study Start Date: | July 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: BMS-823778 (2 mg)
+ metformin
|
Drug: BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days
|
|
Active Comparator: BMS-823778 (10 mg)
+ metformin
|
Drug: BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days
|
|
Active Comparator: BMS-823778 (20 mg)
+ metformin
|
Drug: BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days
|
|
Placebo Comparator: Placebo
+ metformin
|
Drug: Placebo
Capsules, Oral, 0 mg, once 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111955
Locations
| United States, Florida | |
| Farid Marquez, Md | |
| Hialeah, Florida, United States, 33012 | |
| United States, Washington | |
| Capital Clinical Reserch Center | |
| Olympia, Washington, United States, 98502 | |
| United States, Wisconsin | |
| Aurora Advanced Healthcare | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Australia, New South Wales | |
| Local Institution | |
| Blacktown, New South Wales, Australia, 2148 | |
| Australia, Victoria | |
| Local Institution | |
| Box Hill, Victoria, Australia, 3128 | |
| Australia, Western Australia | |
| Local Institution | |
| Freemantle, Western Australia, Australia, 6959 | |
| Canada, British Columbia | |
| Local Institution | |
| Surrey, British Columbia, Canada, V4A 2H9 | |
| Canada, Manitoba | |
| Local Institution | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, New Brunswick | |
| Local Institution | |
| Bathurst, New Brunswick, Canada, E2A 4X7 | |
| Canada, Newfoundland and Labrador | |
| Local Institution | |
| St. John'S, Newfoundland and Labrador, Canada, A1A 3R5 | |
| Canada, Ontario | |
| Local Institution | |
| Thornhill, Ontario, Canada, L4J 8L7 | |
| Canada, Quebec | |
| Local Institution | |
| Mirabel, Quebec, Canada, J7J 2K8 | |
| Canada, Saskatchewan | |
| Local Institution | |
| Saskatoon, Saskatchewan, Canada, S7K 7H9 | |
| Canada | |
| Local Institution | |
| Quebec, Canada, G1N 4V3 | |
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: | NCT01111955 History of Changes |
| Other Study ID Numbers: | MB121-002 |
| Study First Received: | April 26, 2010 |
| Last Updated: | February 22, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013