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MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate (+) metformin hydrochloride
metformin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
  • Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
  • Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
  • Patient is a male, or a female who is unlikely to conceive

Exclusion Criteria:

  • Patient has type 1 diabetes mellitus or history of ketoacidosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Arm 1: drug

    Arm 2: active comparator

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Hemoglobin A1c (A1C) at Week 18
    A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

    Secondary Outcome Measures

    Number of Patients With A1C < 7.0% at Week 18
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
    FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.

    Full Information

    First Posted
    May 31, 2007
    Last Updated
    May 11, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00482729
    Brief Title
    MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
    Official Title
    A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 19, 2007 (Actual)
    Primary Completion Date
    November 3, 2008 (Actual)
    Study Completion Date
    April 27, 2009 (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 this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1246 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Arm 1: drug
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Arm 2: active comparator
    Intervention Type
    Drug
    Intervention Name(s)
    sitagliptin phosphate (+) metformin hydrochloride
    Other Intervention Name(s)
    MK0431A, Janumet™
    Intervention Description
    sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    metformin
    Intervention Description
    metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hemoglobin A1c (A1C) at Week 18
    Description
    A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
    Time Frame
    Baseline and Week 18
    Secondary Outcome Measure Information:
    Title
    Number of Patients With A1C < 7.0% at Week 18
    Time Frame
    Week 18
    Title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
    Description
    FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
    Time Frame
    Baseline and Week 18
    Other Pre-specified Outcome Measures:
    Title
    Change From Baseline in A1C at Week 44
    Description
    A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.
    Time Frame
    Baseline and Week 44
    Title
    Number of Patients With A1C < 7.0% at Week 44
    Time Frame
    Week 44

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient has type 2 diabetes mellitus Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months Patient is a male, or a female who is unlikely to conceive Exclusion Criteria: Patient has type 1 diabetes mellitus or history of ketoacidosis
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    21410627
    Citation
    Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Jul;13(7):644-52. doi: 10.1111/j.1463-1326.2011.01390.x.
    Results Reference
    result
    PubMed Identifier
    21535346
    Citation
    Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011 Sep;13(9):841-9. doi: 10.1111/j.1463-1326.2011.01416.x.
    Results Reference
    result

    Learn more about this trial

    MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

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