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MK0767 and Sulfonylurea Combination Study (0767-027)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0767
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:

  • Type 2 Diabetes with inadequate glycemic control
  • On Sulfonylurea monotherapy
  • Male or non-pregnant Females
  • Age 21 to 78 years, inclusive
  • On a stable dose of sulfonylurea for at least 2 weeks prior to Visit 2/Week-6

Exclusion Criteria:

  • History of Type 1 diabetes
  • Patient is currently on insulin (monotherapy or in combination with oral agent), Rosiglitazone or pioglitazone or other PPAR-y agonists, Metformin agents
  • Patients with history of or intolerance of PPAR-y agonists

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    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
    NCT00543491
    Brief Title
    MK0767 and Sulfonylurea Combination Study (0767-027)
    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
    This study will assess MK0767's ability vs. placebo to control blood glucose in patients with type 2 diabetes and to gauge whether fasting blood glucose is lowered, blood fats are improved, and insulin levels are impacted. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

    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
    129 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0767

    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: Type 2 Diabetes with inadequate glycemic control On Sulfonylurea monotherapy Male or non-pregnant Females Age 21 to 78 years, inclusive On a stable dose of sulfonylurea for at least 2 weeks prior to Visit 2/Week-6 Exclusion Criteria: History of Type 1 diabetes Patient is currently on insulin (monotherapy or in combination with oral agent), Rosiglitazone or pioglitazone or other PPAR-y agonists, Metformin agents Patients with history of or intolerance of PPAR-y agonists
    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

    Learn more about this trial

    MK0767 and Sulfonylurea Combination Study (0767-027)

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