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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01046422
First received: January 11, 2010
Last updated: March 23, 2011
Last verified: September 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014