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MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
Comparator: MK0431 100 mg q.d. (q.d. = once daily)
Comparator: Placebo (Phase A)/Metformin (Phase B)
Comparator: Metformin 500 mg b.i.d.
Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.
Comparator: Metformin 1000 mg b.i.d.
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: 54-Week Base Study: Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes) 50-Week Extension Study: Patients who complete the 54-week base study are eligible to enter the 50-week extension study Exclusion Criteria: Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Arm Label

    1

    2

    3

    4

    5

    6

    7

    Arm Description

    MK0431 100 mg q.d.

    Metformin 500 mg b.i.d.

    Metformin 1000 mg b.i.d.

    Coadministration of MK0431 and Metformin 50/500 mg b.i.d.

    Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.

    Placebo/Metformin 1000 mg b.i.d.

    Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
    HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

    Secondary Outcome Measures

    Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.
    Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.
    Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
    HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
    Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
    Change from baseline at Week 54 is defined as Week 54 minus Week 0.
    Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
    Change from baseline at Week 54 is defined as Week 54 minus Week 0.
    Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104
    HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
    Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.
    Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.

    Full Information

    First Posted
    February 15, 2005
    Last Updated
    March 31, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00103857
    Brief Title
    MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
    Official Title
    A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin 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
    March 17, 2005 (Actual)
    Primary Completion Date
    July 25, 2006 (Actual)
    Study Completion Date
    February 21, 2008 (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
    The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of 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
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1208 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0431 100 mg q.d.
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Metformin 500 mg b.i.d.
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Metformin 1000 mg b.i.d.
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
    Arm Title
    6
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo/Metformin 1000 mg b.i.d.
    Arm Title
    7
    Arm Type
    Experimental
    Arm Description
    Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
    Other Intervention Name(s)
    MK0431
    Intervention Description
    MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: MK0431 100 mg q.d. (q.d. = once daily)
    Intervention Description
    MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo (Phase A)/Metformin (Phase B)
    Intervention Description
    During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Metformin 500 mg b.i.d.
    Intervention Description
    Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.
    Intervention Description
    MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Metformin 1000 mg b.i.d.
    Intervention Description
    Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
    Description
    HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
    Time Frame
    Week 24
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
    Description
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.
    Time Frame
    Week 24
    Title
    Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
    Description
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.
    Time Frame
    Week 24
    Title
    Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
    Description
    HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
    Time Frame
    Week 54
    Title
    Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
    Description
    Change from baseline at Week 54 is defined as Week 54 minus Week 0.
    Time Frame
    Week 54
    Title
    Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
    Description
    Change from baseline at Week 54 is defined as Week 54 minus Week 0.
    Time Frame
    Week 54
    Title
    Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104
    Description
    HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
    Time Frame
    Week 104
    Title
    Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104
    Description
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.
    Time Frame
    Week 104
    Title
    Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104
    Description
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.
    Time Frame
    Week 104

    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: 54-Week Base Study: Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes) 50-Week Extension Study: Patients who complete the 54-week base study are eligible to enter the 50-week extension study Exclusion Criteria: Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
    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
    17485570
    Citation
    Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7. Erratum In: Diabetes Care. 2008 Aug;31(8):1713.
    Results Reference
    background
    PubMed Identifier
    32501595
    Citation
    Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
    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

    MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)

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