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Dyslipidemia in Type 2 Diabetes (0767-034)

Primary Purpose

Diabetes Mellitus, Type II, Dyslipidemia

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 II

Eligibility Criteria

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

Inclusion Criteria:

  • Men and non-pregnant females
  • Age greater than or equal to 21 years
  • Stop current diabetes therapy (if applicable)
  • Stop current statin therapy (if applicable)

Exclusion Criteria:

  • History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin
  • Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks
  • Patients requiring treatment with corticosteroids for more than 14 consecutive days
  • Patients taking warfarin or warfarin-like anti-coagulants
  • Patients undergoing surgery within 30 days of Visit 1
  • Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease
  • Patients with history of pancreatitis or uncontrolled high blood pressure

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2007
    Last Updated
    June 11, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00547274
    Brief Title
    Dyslipidemia in Type 2 Diabetes (0767-034)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    November 2003 (Actual)
    Study Completion Date
    November 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 compare the lipid-altering effects of MK0767, glipizide, and pioglitazone after 12 weeks of treatment. 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 II, Dyslipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    111 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0767

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Men and non-pregnant females Age greater than or equal to 21 years Stop current diabetes therapy (if applicable) Stop current statin therapy (if applicable) Exclusion Criteria: History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks Patients requiring treatment with corticosteroids for more than 14 consecutive days Patients taking warfarin or warfarin-like anti-coagulants Patients undergoing surgery within 30 days of Visit 1 Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease Patients with history of pancreatitis or uncontrolled high blood pressure
    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

    Dyslipidemia in Type 2 Diabetes (0767-034)

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