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A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)

Primary Purpose

Diabetes Mellitus, Type II

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks
Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks
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 - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 21 to 70, You are a man or non-pregnant woman

Exclusion Criteria:

  • Have a history of type I diabetes
  • You are on a weight loss program with ongoing weight loss or taking weight loss medications
  • You have a history of minor surgery
  • You have received investigational drugs within 8 weeks of study start
  • You have hepatitis B or C

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To asses the effectiveness of MK0431 compared to placebo

    Secondary Outcome Measures

    To test the safety and tolerability of MK0431 in patients with type 2 diabetes

    Full Information

    First Posted
    June 1, 2007
    Last Updated
    March 24, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00482079
    Brief Title
    A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)
    Official Title
    A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled Dose-Range Finding Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 13, 2003 (Actual)
    Primary Completion Date
    August 25, 2004 (Actual)
    Study Completion Date
    June 15, 2006 (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
    A dose-ranging study of MK0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    743 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MK0431, sitagliptin phosphate / Duration of Treatment: 21 Weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified) / Duration of Treatment: 21 Weeks
    Primary Outcome Measure Information:
    Title
    To asses the effectiveness of MK0431 compared to placebo
    Time Frame
    over 12 weeks
    Secondary Outcome Measure Information:
    Title
    To test the safety and tolerability of MK0431 in patients with type 2 diabetes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 21 to 70, You are a man or non-pregnant woman Exclusion Criteria: Have a history of type I diabetes You are on a weight loss program with ongoing weight loss or taking weight loss medications You have a history of minor surgery You have received investigational drugs within 8 weeks of study start You have hepatitis B or C
    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

    Citations:
    PubMed Identifier
    17156104
    Citation
    Scott R, Wu M, Sanchez M, Stein P. Efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes. Int J Clin Pract. 2007 Jan;61(1):171-80. doi: 10.1111/j.1742-1241.2006.01246.x. Epub 2006 Dec 5.
    Results Reference
    background
    PubMed Identifier
    25633134
    Citation
    Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30. Erratum In: Diabetes Ther. 2015 Mar;6(1):97-8.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    A Study of MK0431 in Patients With Type 2 Diabetes (0431-010)

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