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MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

Primary Purpose

Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: Placebo
Sitagliptin
Voglibose
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy

Exclusion Criteria:

  • Patients Have A History Of Type 1 Diabetes Mellitus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Sitagliptin/Sitagliptin

    Placebo/Sitagliptin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).

    Secondary Outcome Measures

    Change From Baseline in 2-hour Postprandial Glucose at Week 12
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.

    Full Information

    First Posted
    February 3, 2009
    Last Updated
    April 10, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00837577
    Brief Title
    MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
    Official Title
    A Phase III, Randomized, Placebo-controlled, Double-blind Clinical Trial and Subsequent Open-label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of Sitagliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Voglibose Monotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 5, 2009 (Actual)
    Primary Completion Date
    August 11, 2010 (Actual)
    Study Completion Date
    August 11, 2010 (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 phase III clinical trial examines the efficacy, safety, and tolerability of the addition of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on diet/exercise therapy and voglibose monotherapy

    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 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    133 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin/Sitagliptin
    Arm Type
    Experimental
    Arm Title
    Placebo/Sitagliptin
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo to sitagliptin once daily for 12 weeks (double-blind period)
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin
    Other Intervention Name(s)
    Januvia, MK0431, ONO-5435
    Intervention Description
    Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.
    Intervention Type
    Drug
    Intervention Name(s)
    Voglibose
    Intervention Description
    All participants received a stable dose of voglibose, in accordance with the package insert, throughout the study.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
    Description
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c [National Glycohemoglobin Standardization Program; NGSP] = HbA1c (JDS-HbA1c [%]) + 0.4%).
    Time Frame
    Baseline and Week 12
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in 2-hour Postprandial Glucose at Week 12
    Description
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
    Time Frame
    Baseline and Week 12
    Title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
    Description
    Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication.
    Time Frame
    Baseline and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy Exclusion Criteria: Patients Have A History Of 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

    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
    24843714
    Citation
    Tajima N, Kadowaki T, Okamoto T, Sato A, Okuyama K, Minamide T, Arjona Ferreira JC. Sitagliptin added to voglibose monotherapy improves glycemic control in patients with type 2 diabetes. J Diabetes Investig. 2013 Nov 27;4(6):595-604. doi: 10.1111/jdi.12116. Epub 2013 Jul 21.
    Results Reference
    result

    Learn more about this trial

    MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)

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