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

September 23, 2015 updated by: Bristol-Myers Squibb

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Within seven days following dosing
Within seven days following dosing

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • MB117-003
  • 2009-014308-79 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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