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Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0767
Comparator: placebo (unspecified)
Comparator: metformin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients are men and non-pregnant women ages 21 to 78 years
  • Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study

Exclusion Criteria:

  • Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
  • Patients undergoing surgery within 30 days of Visit 1
  • Patients taking Warfin or Warfin-like anticoagulants
  • Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9

Sites / Locations

    Outcomes

    Primary Outcome Measures

    This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.

    Secondary Outcome Measures

    MK0767 will be safe and well tolerated.

    Full Information

    First Posted
    October 5, 2007
    Last Updated
    June 11, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00543361
    Brief Title
    Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
    Official Title
    A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    December 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    382 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0767
    Intervention Description
    Duration of Treatment: 52 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified)
    Intervention Description
    Duration of Treatment: 52 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: metformin
    Intervention Description
    Duration of Treatment: 52 Weeks
    Primary Outcome Measure Information:
    Title
    This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
    Time Frame
    over the course of 52 weeks
    Secondary Outcome Measure Information:
    Title
    MK0767 will be safe and well tolerated.
    Time Frame
    over the course of 52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients are men and non-pregnant women ages 21 to 78 years Patients either not on antihyperglycemic medications (>8 weeks), or being treated with a single oral antihyperglycemic agent & willing to discontinue therapy for the duration of the study Exclusion Criteria: Patient has history of type 1 diabetes mellitus and or history of ketoacidosis Patients undergoing surgery within 30 days of Visit 1 Patients taking Warfin or Warfin-like anticoagulants Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)

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