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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: BMS-823778; Drug: BMS-823778; Drug: BMS-823778; Drug: Placebo; Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Local Institution
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Local Institution
  • Western Australia
    • Freemantle, Western Australia, Australia, 6959
      • Local Institution
• Canada
  • Quebec, Canada, G1N 4V3
    • Local Institution
  • British Columbia
    • Surrey, British Columbia, Canada, V4A 2H9
      • Local Institution
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • Local Institution
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4X7
      • Local Institution
  • Newfoundland and Labrador
    • St. John'S, Newfoundland and Labrador, Canada, A1A 3R5
      • Local Institution
  • Ontario
    • Thornhill, Ontario, Canada, L4J 8L7
      • Local Institution
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Local Institution
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 7H9
      • Local Institution
• United States
  • Florida
    • Hialeah, Florida, United States, 33012
      • Farid Marquez, Md
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clinical Reserch Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Aurora Advanced Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BMS-823778 (2 mg); + metformin	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: Metformin; Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Active Comparator: BMS-823778 (10 mg); + metformin	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: Metformin; Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Active Comparator: BMS-823778 (20 mg); + metformin	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: Metformin; Capsules, Oral, ≥ 1500 mg, once daily, 28 days
Placebo Comparator: Placebo; + metformin	Drug: Placebo; Capsules, Oral, 0 mg, once daily, 28 days; Drug: Metformin; Capsules, Oral, ≥ 1500 mg, once daily, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline	Within 28 days following dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (measuring trough concentrations)	On days 7, 14 and 28
Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)	Within 28 days following dosing

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 28, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: MB121-002