Safety Study of BMS-770767 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-770767 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 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

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2
• Intervention / Treatment: Drug: BMS-770767; Drug: BMS-770767; Drug: BMS-770767; Drug: BMS-770767; Drug: Metformin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Caboolture, Queensland, Australia, 4510
      • Local Institution
    • Meadowbrook, Queensland, Australia, 4131
      • Local Institution
  • South Australia
    • Daw Park, South Australia, Australia, 5041
      • Local Institution
  • Victoria
    • Geelong, Victoria, Australia, 3220
      • Local Institution
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Local Institution
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3P 1R9
      • Local Institution
  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
      • Local Institution
  • Ontario
    • Brampton, Ontario, Canada, L6T 3J1
      • Local Institution
    • Toronto, Ontario, Canada, M4G 3E8
      • Local Institution
  • Prince Edward Island
    • Charlottetown, Prince Edward Island, Canada, C1A 5Y9
      • Local Institution
  • Quebec
    • 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
      • Local Institution
• Korea, Republic of
  • Incheon, Korea, Republic of, 405-760
    • Local Institution
  • Suwon, Korea, Republic of, 443-721
    • Local Institution
• United States
  • California
    • Lomita, California, United States, 90717
      • Marina Raikhel, Md
  • Nevada
    • Las Vegas, Nevada, United States, 89101
      • Nevada Alliance Against Diabetes

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-770767 ± metformin (Treatment A)	Drug: BMS-770767; Capsule, Oral, 15mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 50mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 150mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 50mg BID, Active, Daily, 28 days; Drug: Metformin; Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Experimental: BMS-770767 ± metformin (Treatment B)	Drug: BMS-770767; Capsule, Oral, 15mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 50mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 150mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 50mg BID, Active, Daily, 28 days; Drug: Metformin; Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Experimental: BMS-770767 ± metformin (Treatment C)	Drug: BMS-770767; Capsule, Oral, 15mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 50mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 150mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 50mg BID, Active, Daily, 28 days; Drug: Metformin; Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days
Experimental: BMS-770767 ± metformin (Treatment D)	Drug: BMS-770767; Capsule, Oral, 15mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 50mg, Active, Daily, 28 days; Drug: BMS-770767; Capsule, Oral, 150mg, Active, Daily, 28 days; 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: Metformin; Tablet, Oral, ≥ 1500mg, Active, Daily, 28 days; Drug: Placebo; Capsule, Oral, 0mg, Daily, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting Plasma Glucose Improvement	Within seven days following dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean daily glucose (3-day 7 pt-fingerstick)	Within 28 days following dosing
Four (4)-hour post-prandial glucose AUC	Within 28 days following dosing
HbA1C	Within 28 days following dosing
Lipid profiles	Within 28 days following dosing

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 11, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 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: MB117-003; 2009-014308-79 (EudraCT Number)