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Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

Primary Purpose

Glucose Intolerance

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo for Sitagliptin 25 mg
Placebo for Sitagliptin 50 mg
Sitagliptin 25 mg
Sitagliptin 50 mg
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glucose Intolerance

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Impaired glucose tolerance
  • On diet/exercise therapy
  • Unlikely to conceive
  • Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

Exclusion Criteria:

  • History of diabetes mellitus
  • Disease or condition of clear or likely glucose tolerance disorder
  • Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo

    Sitagliptin 25 mg

    Sitagliptin 50 mg

    Arm Description

    Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.

    Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.

    Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8
    Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal.
    Percentage of Participants Who Experienced One or More Adverse Events (AEs)
    An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
    Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
    An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

    Secondary Outcome Measures

    Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7
    Glucose total AUC 0-2 hours for 75 g OGTT was measured at Baseline (Week -1) and at Week 7. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at 75 g glucose loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 7, participants received study drug or placebo 30 minutes prior to loading 75 g glucose solution.

    Full Information

    First Posted
    July 28, 2011
    Last Updated
    January 3, 2020
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01405911
    Brief Title
    Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)
    Official Title
    A Phase II, Randomized, Placebo-Controlled, Parallel-group, Double-Blind, Dose Response Finding Clinical Trial to Study the Efficacy and Safety of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 16, 2011 (Actual)
    Primary Completion Date
    April 9, 2012 (Actual)
    Study Completion Date
    April 9, 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 is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucose Intolerance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    242 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
    Arm Title
    Sitagliptin 25 mg
    Arm Type
    Experimental
    Arm Description
    Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.
    Arm Title
    Sitagliptin 50 mg
    Arm Type
    Experimental
    Arm Description
    Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Sitagliptin 25 mg
    Intervention Description
    1 tablet orally once daily before breakfast for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Sitagliptin 50 mg
    Intervention Description
    1 tablet orally once daily before breakfast for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin 25 mg
    Other Intervention Name(s)
    MK-0431/ONO-5435
    Intervention Description
    1 tablet orally once daily before breakfast for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin 50 mg
    Other Intervention Name(s)
    MK-0431/ONO-5435
    Intervention Description
    1 tablet orally once daily before breakfast for 8 weeks
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8
    Description
    Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal.
    Time Frame
    Baseline (Week 0) and Week 8
    Title
    Percentage of Participants Who Experienced One or More Adverse Events (AEs)
    Description
    An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
    Time Frame
    Up to 10 weeks
    Title
    Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)
    Description
    An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
    Time Frame
    Up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7
    Description
    Glucose total AUC 0-2 hours for 75 g OGTT was measured at Baseline (Week -1) and at Week 7. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at 75 g glucose loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 7, participants received study drug or placebo 30 minutes prior to loading 75 g glucose solution.
    Time Frame
    Baseline (Week -1) and Week 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Impaired glucose tolerance On diet/exercise therapy Unlikely to conceive Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL Exclusion Criteria: History of diabetes mellitus Disease or condition of clear or likely glucose tolerance disorder Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    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://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    26094974
    Citation
    Kaku K, Kadowaki T, Terauchi Y, Okamoto T, Sato A, Okuyama K, Arjona Ferreira JC, Goldstein BJ. Sitagliptin improves glycaemic excursion after a meal or after an oral glucose load in Japanese subjects with impaired glucose tolerance. Diabetes Obes Metab. 2015 Nov;17(11):1033-41. doi: 10.1111/dom.12507. Epub 2015 Jul 17.
    Results Reference
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    Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

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