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Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sitagliptin 50 mg
Metformin 500 mg
Sitagliptin 100 mg
Placebo
Metformin 850 mg
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:

  • has type 2 diabetes mellitus
  • is male, a female who cannot have children, or a female who agrees to use birth control during the study
  • is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

  • Patient has type 1 diabetes mellitus or ketoacidosis
  • Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
  • Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
  • Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
  • Patient is HIV positive
  • Patient is pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Sitagliptin 50 mg + metformin 500 mg

    Sitagliptin 50 mg + metformin 850 mg

    Metformin 500 mg

    Metformin 850 mg

    Sitagliptin 100 mg

    Placebo

    Arm Description

    Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks.

    Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.

    Metformin 500 mg twice daily for 24 weeks.

    Metformin 850 mg twice daily for 24 weeks.

    Sitagliptin 100 mg once daily for 24 weeks.

    Matching placebo tablets for 24 weeks.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Hemoglobin A1C (A1C) at Week 24
    A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

    Secondary Outcome Measures

    Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24
    Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
    Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.

    Full Information

    First Posted
    February 24, 2010
    Last Updated
    April 27, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01076088
    Brief Title
    Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
    Official Title
    A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 15, 2010 (Actual)
    Primary Completion Date
    December 24, 2012 (Actual)
    Study Completion Date
    December 24, 2012 (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
    This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

    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
    744 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin 50 mg + metformin 500 mg
    Arm Type
    Experimental
    Arm Description
    Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks.
    Arm Title
    Sitagliptin 50 mg + metformin 850 mg
    Arm Type
    Experimental
    Arm Description
    Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks.
    Arm Title
    Metformin 500 mg
    Arm Type
    Active Comparator
    Arm Description
    Metformin 500 mg twice daily for 24 weeks.
    Arm Title
    Metformin 850 mg
    Arm Type
    Active Comparator
    Arm Description
    Metformin 850 mg twice daily for 24 weeks.
    Arm Title
    Sitagliptin 100 mg
    Arm Type
    Experimental
    Arm Description
    Sitagliptin 100 mg once daily for 24 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Matching placebo tablets for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin 50 mg
    Other Intervention Name(s)
    Januvia®, Tesavel®, Xelevia®, Ristaben®
    Intervention Description
    Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin 500 mg
    Other Intervention Name(s)
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Intervention Description
    Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin 100 mg
    Other Intervention Name(s)
    Januvia®, Tesavel®, Xelevia®, Ristaben®
    Intervention Description
    Sitagliptin 100 mg once daily for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo tablets to sitagliptin or metformin for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin 850 mg
    Other Intervention Name(s)
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Intervention Description
    Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hemoglobin A1C (A1C) at Week 24
    Description
    A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
    Time Frame
    Baseline and Week 24
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in 2-hour Post Meal Glucose (2-h PMG) at Week 24
    Description
    Change from baseline in 2-h PMG at Week 24 is defined as Week 24 2-h PMG minus Week 0 2-h PMG.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
    Description
    Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
    Time Frame
    Baseline and Week 24

    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: has type 2 diabetes mellitus is male, a female who cannot have children, or a female who agrees to use birth control during the study is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%) Exclusion Criteria: Patient has type 1 diabetes mellitus or ketoacidosis Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) Patient is on a weight loss program not in the maintenance phase or on a weight loss medication Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer Patient is HIV positive Patient is pregnant
    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
    27181998
    Citation
    Ji L, Han P, Wang X, Liu J, Zheng S, Jou YM, O'Neill EA, Golm GT, Engel SS, Kaufman KD, Shankar RR. Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus. J Diabetes Investig. 2016 Sep;7(5):727-36. doi: 10.1111/jdi.12511. Epub 2016 May 19.
    Results Reference
    result

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    Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

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