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MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate (+) metformin hydrochloride
Comparator: pioglitazone
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

General Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
  • Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Sitagliptin phosphate (+) metformin hydrochloride

    pioglitazone

    Outcomes

    Primary Outcome Measures

    Change From Baseline in A1C at Week 32
    A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent

    Secondary Outcome Measures

    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1
    Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone
    Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32
    Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG
    Change From Baseline in FPG at Week 32
    Change from baseline reflects the Week 32 FPG minus the baseline FPG
    Percent of Participants With A1C <7.0% at Week 32

    Full Information

    First Posted
    September 19, 2007
    Last Updated
    May 11, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00532935
    Brief Title
    MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
    Official Title
    A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 26, 2008 (Actual)
    Primary Completion Date
    October 23, 2009 (Actual)
    Study Completion Date
    October 23, 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
    A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

    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
    517 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Sitagliptin phosphate (+) metformin hydrochloride
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    pioglitazone
    Intervention Type
    Drug
    Intervention Name(s)
    sitagliptin phosphate (+) metformin hydrochloride
    Other Intervention Name(s)
    Janumet
    Intervention Description
    sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: pioglitazone
    Other Intervention Name(s)
    pioglitazone
    Intervention Description
    pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in A1C at Week 32
    Description
    A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent
    Time Frame
    Baseline and Week 32
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1
    Description
    Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone
    Time Frame
    Baseline and Week 1
    Title
    Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32
    Description
    Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG
    Time Frame
    Baseline and Week 32
    Title
    Change From Baseline in FPG at Week 32
    Description
    Change from baseline reflects the Week 32 FPG minus the baseline FPG
    Time Frame
    Baseline and Week 32
    Title
    Percent of Participants With A1C <7.0% at Week 32
    Time Frame
    Week 32

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    General Inclusion Criteria: Patient has type 2 diabetes mellitus Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy General Exclusion Criteria: Patient has a history of type 1 diabetes mellitus or history of ketoacidosis Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
    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
    22059736
    Citation
    Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.
    Results Reference
    result

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    MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

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