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A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sitagliptin phosphate
Comparator: placebo to pioglitazone
Comparator: placebo to Sitagliptin
Comparator: pioglitazone
Glimepiride or gliclazide
Metformin
Pioglitazone rescue therapy
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 focused on measuring Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Hemoglobin A1C of ≥7.5% and ≤10.5%
  • Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
  • Male, or a female who is highly unlikely to conceive

Exclusion Criteria:

  • Type 1 diabetes mellitus or ketoacidosis
  • Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
  • On a weight loss program not in the maintenance phase or on a weight loss medication
  • History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
  • HIV positive
  • Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    placebo/pioglitazone

    Sitagliptin

    Arm Description

    Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg

    Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Hemoglobin A1C (%) at Week 24
    Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.
    Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54
    Number of Participants Discontinuing Study Drug Due to An Adverse Event

    Secondary Outcome Measures

    Change From Baseline in 2-hour Post-Meal Glucose at Week 24
    Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.
    Change From Baseline in Fasting Plasma Glucose at Week 24
    Change from baseline reflects the Week 24 value minus the baseline value.

    Full Information

    First Posted
    February 24, 2010
    Last Updated
    May 4, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01076075
    Brief Title
    A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
    Official Title
    A Phase III, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 3, 2010 (Actual)
    Primary Completion Date
    July 11, 2011 (Actual)
    Study Completion Date
    January 19, 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 evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    427 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo/pioglitazone
    Arm Type
    Active Comparator
    Arm Description
    Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): placebo to Sitagliptin 100 mg + pioglitazone 30 mg
    Arm Title
    Sitagliptin
    Arm Type
    Experimental
    Arm Description
    Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + placebo to pioglitazone
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin phosphate
    Other Intervention Name(s)
    Januvia
    Intervention Description
    Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo to pioglitazone
    Intervention Description
    Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo to Sitagliptin
    Intervention Description
    Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: pioglitazone
    Other Intervention Name(s)
    Actos;
    Intervention Description
    Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Glimepiride or gliclazide
    Intervention Description
    Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of metformin; Phase B (Weeks 24- 54): stable dose, as prescribed by investigator, of metformin
    Intervention Type
    Drug
    Intervention Name(s)
    Pioglitazone rescue therapy
    Other Intervention Name(s)
    Actos
    Intervention Description
    Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Hemoglobin A1C (%) at Week 24
    Description
    Change from baseline reflects the Week 24 value minus the baseline value. A1C represents the percentage of glycosylated hemoglobin.
    Time Frame
    Baseline and Week 24
    Title
    Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54
    Time Frame
    Week 0 to Week 54
    Title
    Number of Participants Discontinuing Study Drug Due to An Adverse Event
    Time Frame
    Week 0 to Week 54
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in 2-hour Post-Meal Glucose at Week 24
    Description
    Change from baseline reflects the Week 24 value minus the baseline value. Two-hour post-meal glucose was measured following a standard meal.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline in Fasting Plasma Glucose at Week 24
    Description
    Change from baseline reflects the Week 24 value minus the baseline value.
    Time Frame
    Baseline to 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: Type 2 diabetes mellitus Hemoglobin A1C of ≥7.5% and ≤10.5% Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start Male, or a female who is highly unlikely to conceive Exclusion Criteria: Type 1 diabetes mellitus or ketoacidosis Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start On a weight loss program not in the maintenance phase or on a weight loss medication History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer HIV positive 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
    26625270
    Citation
    Moses RG, Round E, Shentu Y, Golm GT, O'neill EA, Gantz I, Engel SS, Kaufman KD, Goldstein BJ. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. J Diabetes. 2016 Sep;8(5):701-11. doi: 10.1111/1753-0407.12351. Epub 2016 Feb 3.
    Results Reference
    result

    Learn more about this trial

    A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)

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