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An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sitagliptin (MK0431)
Comparator: glipizide
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, Type 2

Eligibility Criteria

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

Inclusion Criteria: Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sitagliptin 100 mg

    Glipizide

    Arm Description

    Sitagliptin 100 mg oral tablets of sitagliptin once daily.

    Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in HbA1c at Week 52
    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.

    Secondary Outcome Measures

    Change From Baseline in HbA1c at Week 104
    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
    Change From Baseline in Body Weight at Week 52
    Change from baseline at Week 52 is defined as Week 52 minus Week 0.
    Change From Baseline in Body Weight at Week 104
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.
    Hypoglycemic Events at Week 52
    Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
    Hypoglycemic Events at Week 104
    Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
    Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
    Number of Participants With Serious CAEs at Week 104
    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
    Number of Participants With Drug-related CAEs at Week 104
    Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
    Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
    Number of Participants With Serious LAEs at Week 104
    Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
    Number of Participants With Drug-related LAEs at Week 104
    Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.

    Full Information

    First Posted
    October 22, 2004
    Last Updated
    August 25, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00094770
    Brief Title
    An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
    Official Title
    A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK0431 Compared With Sulfonylurea Therapy in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2007 (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
    The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).
    Detailed Description
    The duration of treatment is 104 weeks.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1172 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin 100 mg
    Arm Type
    Experimental
    Arm Description
    Sitagliptin 100 mg oral tablets of sitagliptin once daily.
    Arm Title
    Glipizide
    Arm Type
    Active Comparator
    Arm Description
    Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
    Intervention Type
    Drug
    Intervention Name(s)
    sitagliptin (MK0431)
    Other Intervention Name(s)
    MK0431
    Intervention Description
    Sitagliptin 100 mg oral tablets of sitagliptin once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: glipizide
    Other Intervention Name(s)
    Glipizide
    Intervention Description
    Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in HbA1c at Week 52
    Description
    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.
    Time Frame
    Baseline and Week 52
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in HbA1c at Week 104
    Description
    HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
    Time Frame
    Baseline and Week 104
    Title
    Change From Baseline in Body Weight at Week 52
    Description
    Change from baseline at Week 52 is defined as Week 52 minus Week 0.
    Time Frame
    Baseline and Week 52
    Title
    Change From Baseline in Body Weight at Week 104
    Description
    Change from baseline at Week 104 is defined as Week 104 minus Week 0.
    Time Frame
    Baseline and Week 104
    Title
    Hypoglycemic Events at Week 52
    Description
    Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.
    Time Frame
    Baseline to Week 52
    Title
    Hypoglycemic Events at Week 104
    Description
    Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.
    Time Frame
    Baseline to Week 104
    Title
    Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104
    Description
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
    Time Frame
    Baseline to Week 104
    Title
    Number of Participants With Serious CAEs at Week 104
    Description
    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.
    Time Frame
    Baseline to Week 104
    Title
    Number of Participants With Drug-related CAEs at Week 104
    Description
    Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.
    Time Frame
    Baseline to Week 104
    Title
    Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104
    Description
    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
    Time Frame
    Baseline to Week 104
    Title
    Number of Participants With Serious LAEs at Week 104
    Description
    Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
    Time Frame
    Baseline to Week 104
    Title
    Number of Participants With Drug-related LAEs at Week 104
    Description
    Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.
    Time Frame
    Baseline to Week 104

    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: Patients who are at least 18 years of age and not older than 78 with type 2 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

    Citations:
    PubMed Identifier
    17300595
    Citation
    Nauck MA, Meininger G, Sheng D, Terranella L, Stein PP; Sitagliptin Study 024 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, compared with the sulfonylurea, glipizide, in patients with type 2 diabetes inadequately controlled on metformin alone: a randomized, double-blind, non-inferiority trial. Diabetes Obes Metab. 2007 Mar;9(2):194-205. doi: 10.1111/j.1463-1326.2006.00704.x.
    Results Reference
    background
    PubMed Identifier
    25633134
    Citation
    Ommen ES, Xu L, O'Neill EA, Goldstein BJ, Kaufman KD, Engel SS. Comparison of treatment with sitagliptin or sulfonylurea in patients with type 2 diabetes mellitus and mild renal impairment: a post hoc analysis of clinical trials. Diabetes Ther. 2015 Mar;6(1):29-40. doi: 10.1007/s13300-015-0098-y. Epub 2015 Jan 30. Erratum In: Diabetes Ther. 2015 Mar;6(1):97-8.
    Results Reference
    derived
    PubMed Identifier
    21477878
    Citation
    Seck TL, Engel SS, Williams-Herman DE, Sisk CM, Golm GT, Wang H, Kaufman KD, Goldstein BJ. Sitagliptin more effectively achieves a composite endpoint for A1C reduction, lack of hypoglycemia and no body weight gain compared with glipizide. Diabetes Res Clin Pract. 2011 Jul;93(1):e15-7. doi: 10.1016/j.diabres.2011.03.006. Epub 2011 Apr 8.
    Results Reference
    derived
    PubMed Identifier
    20456211
    Citation
    Seck T, Nauck M, Sheng D, Sunga S, Davies MJ, Stein PP, Kaufman KD, Amatruda JM; Sitagliptin Study 024 Group. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract. 2010 Apr;64(5):562-76. doi: 10.1111/j.1742-1241.2010.02353.x.
    Results Reference
    derived

    Learn more about this trial

    An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)

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