Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01111955
First received: April 26, 2010
Last updated: February 22, 2011
Last verified: February 2011
  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
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: 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 July 24, 2014