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Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

Primary Purpose

Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate
Comparator: Placebo
Comparator: Sitagliptin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Exclusion Criteria:

  • Patients Have Type 1 Diabetes Mellitus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    Arm Description

    Placebo

    Sitagliptin 100 mg

    Sitagliptin 50 mg

    Outcomes

    Primary Outcome Measures

    Change From Baseline in 24-hour Weighted Mean Plasma Glucose
    Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.

    Secondary Outcome Measures

    Change From Baseline in Plasma Glucose
    Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.

    Full Information

    First Posted
    September 22, 2008
    Last Updated
    March 31, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00758069
    Brief Title
    Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
    Official Title
    Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 3, 2005 (Actual)
    Primary Completion Date
    February 13, 2006 (Actual)
    Study Completion Date
    February 13, 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Non-Insulin-Dependent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Sitagliptin 100 mg
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Sitagliptin 50 mg
    Intervention Type
    Drug
    Intervention Name(s)
    sitagliptin phosphate
    Other Intervention Name(s)
    MK0431
    Intervention Description
    100 mg once daily (QD), taken orally for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo tablet, QD, taken orally for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Sitagliptin
    Other Intervention Name(s)
    MK0431
    Intervention Description
    50 mg twice daily (BID), taken orally for 4 weeks
    Primary Outcome Measure Information:
    Title
    Change From Baseline in 24-hour Weighted Mean Plasma Glucose
    Description
    Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
    Time Frame
    Baseline and Week 4
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Plasma Glucose
    Description
    Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.
    Time Frame
    Baseline and Week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy Exclusion Criteria: Patients Have Type 1 Diabetes Mellitus
    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
    19253204
    Citation
    Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.
    Results Reference
    background
    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

    Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

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