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Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sitagliptin (MK0431)
Sitagliptin
Placebo
Placebo
Metformin - Rescue
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with type 2 diabetes mellitus Patient is not pregnant or breastfeeding Male or female patient unlikely to conceive Patient not on an antihyperglycemic drug Exclusion Criteria: Patient has history of type 1 diabetes mellitus Patient has history of ketoacidosis Patient requires insulin within 8 weeks prior to start of study Patient on weight loss program and is not in maintenance phase Patient taking weight loss medication within 8 weeks prior to start of study Patient on or likely to require = 14 days or repeated courses of corticosteroids Patient taking immunosuppressive/immunomodulating medication Patient taking digoxin or other cardiac medication Patient has undergone surgical general anesthesia within 30 days prior to start of study Patient taking investigational drug within 8 weeks prior to start of study Patient is diagnosed with liver disease Patient has chronic myopathy, progressive neurological/neuromuscular disorder Patient has with severe cardiac conditions within the last 6 months Patient is Human immunodeficiency virus (HIV) positive Patient has hematological disorder Patient has history of malignancy Patient has history of alcohol or drug abuse within the past 3 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Sitagliptin 100 mg/100 mg

    Sitagliptin 200 mg/200 mg

    Placebo/Sitagliptin 100 mg

    Placebo/Sitagliptin 200 mg

    Arm Description

    Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )

    Phase A and B: Oral tablets of sitagliptin 200 mg q.d

    Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.

    Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.

    Outcomes

    Primary Outcome Measures

    Change From Baseline in A1C at Week 24
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

    Secondary Outcome Measures

    Change From Baseline in FPG at Week 24
    Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
    Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
    Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
    Change From Baseline in A1C at Week 104
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.
    Change From Baseline in FPG at Week 104
    Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.
    Change From Baseline in 2-hr PMG at Week 104
    Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.

    Full Information

    First Posted
    July 9, 2004
    Last Updated
    June 8, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00087516
    Brief Title
    Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
    Official Title
    A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    July 2005 (Actual)
    Study Completion Date
    February 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 clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

    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
    741 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin 100 mg/100 mg
    Arm Type
    Active Comparator
    Arm Description
    Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )
    Arm Title
    Sitagliptin 200 mg/200 mg
    Arm Type
    Active Comparator
    Arm Description
    Phase A and B: Oral tablets of sitagliptin 200 mg q.d
    Arm Title
    Placebo/Sitagliptin 100 mg
    Arm Type
    Placebo Comparator
    Arm Description
    Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.
    Arm Title
    Placebo/Sitagliptin 200 mg
    Arm Type
    Placebo Comparator
    Arm Description
    Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin (MK0431)
    Other Intervention Name(s)
    MK0431, Januvia
    Intervention Description
    Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin
    Other Intervention Name(s)
    MK0431, Januvia
    Intervention Description
    Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin - Rescue
    Other Intervention Name(s)
    Metformin, Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet
    Intervention Description
    Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in A1C at Week 24
    Description
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
    Time Frame
    Weeks 0-24
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in FPG at Week 24
    Description
    Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
    Time Frame
    Weeks 0-24
    Title
    Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24
    Description
    Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
    Time Frame
    Weeks 0-24
    Title
    Change From Baseline in A1C at Week 104
    Description
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.
    Time Frame
    Weeks 0-104
    Title
    Change From Baseline in FPG at Week 104
    Description
    Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.
    Time Frame
    Weeks 0-104
    Title
    Change From Baseline in 2-hr PMG at Week 104
    Description
    Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.
    Time Frame
    Weeks 0-104

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with type 2 diabetes mellitus Patient is not pregnant or breastfeeding Male or female patient unlikely to conceive Patient not on an antihyperglycemic drug Exclusion Criteria: Patient has history of type 1 diabetes mellitus Patient has history of ketoacidosis Patient requires insulin within 8 weeks prior to start of study Patient on weight loss program and is not in maintenance phase Patient taking weight loss medication within 8 weeks prior to start of study Patient on or likely to require = 14 days or repeated courses of corticosteroids Patient taking immunosuppressive/immunomodulating medication Patient taking digoxin or other cardiac medication Patient has undergone surgical general anesthesia within 30 days prior to start of study Patient taking investigational drug within 8 weeks prior to start of study Patient is diagnosed with liver disease Patient has chronic myopathy, progressive neurological/neuromuscular disorder Patient has with severe cardiac conditions within the last 6 months Patient is Human immunodeficiency virus (HIV) positive Patient has hematological disorder Patient has history of malignancy Patient has history of alcohol or drug abuse within the past 3 years
    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
    17130196
    Citation
    Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.
    Results Reference
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    Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

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