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Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

Primary Purpose

Type 2 Diabetes Mellitus (T2DM)

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: sitagliptin phosphate
Comparator: placebo (unspecified)
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 (T2DM)

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant has type 2 diabetes mellitus
  • Males
  • Females who are highly unlikely to become pregnant
  • Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications

Exclusion Criteria:

  • Participant has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Participant required insulin therapy within the prior 8 weeks
  • Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    sitagliptin

    Placebo

    Arm Description

    Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.

    Participants randomized to this arm will be administered matching placebo, daily for six weeks.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
    Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 23, 2008
    Last Updated
    April 6, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00704132
    Brief Title
    Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
    Official Title
    A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 14, 2007 (Actual)
    Primary Completion Date
    April 28, 2010 (Actual)
    Study Completion Date
    April 28, 2010 (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 clinical study to determine the safety, efficacy and the way sitagliptin works in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus (T2DM)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    sitagliptin
    Arm Type
    Experimental
    Arm Description
    Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants randomized to this arm will be administered matching placebo, daily for six weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: sitagliptin phosphate
    Intervention Description
    Sitagliptin tablet 100 mg, administered once daily before the morning meal.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo (unspecified)
    Intervention Description
    Matching placebo tablet, administered once daily before the morning meal.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6
    Description
    Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
    Time Frame
    Baseline and Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participant has type 2 diabetes mellitus Males Females who are highly unlikely to become pregnant Participants poorly controlled without taking any, or taking one or two oral antidiabetic medications Exclusion Criteria: Participant has a history of type 1 diabetes mellitus or history of ketoacidosis Participant required insulin therapy within the prior 8 weeks Participant is on or has been taking TZDs such as Actos® (pioglitazone) or Avandia® (rosiglitazone) within the prior 12 weeks of the screening visit
    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
    22685234
    Citation
    Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.
    Results Reference
    derived

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    Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)

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