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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01111955
First received: April 26, 2010
Last updated: September 23, 2015
Last verified: September 2015

April 26, 2010
September 23, 2015
July 2010
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01111955 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety Study of BMS-823778 in Subjects With Type 2 Diabetes
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
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: BMS-823778
    Capsules, Oral, 2 mg, once daily, 28 days
  • Drug: BMS-823778
    Capsules, Oral, 10 mg, once daily, 28 days
  • Drug: BMS-823778
    Capsules, Oral, 20 mg, once daily, 28 days
  • Drug: Placebo
    Capsules, Oral, 0 mg, once daily, 28 days
  • Drug: Metformin
    Capsules, Oral, ≥ 1500 mg, once daily, 28 days
  • Active Comparator: BMS-823778 (2 mg)
    + metformin
    Interventions:
    • Drug: BMS-823778
    • Drug: Metformin
  • Active Comparator: BMS-823778 (10 mg)
    + metformin
    Interventions:
    • Drug: BMS-823778
    • Drug: Metformin
  • Active Comparator: BMS-823778 (20 mg)
    + metformin
    Interventions:
    • Drug: BMS-823778
    • Drug: Metformin
  • Placebo Comparator: Placebo
    + metformin
    Interventions:
    • Drug: Placebo
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
January 2011
January 2011   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT01111955
MB121-002
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP