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Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK-0941
Comparator: Placebo
Lantus
Metformin
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

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

Inclusion Criteria:

  • has type 2 diabetes mellitus
  • has body mass index >20 and <43 kg/m^2
  • is a male, or a female who is unlikely to conceive
  • currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus

Extension Study Inclusion Criteria:

  • completed the base study either on double-blind study medication or as part of the post-treatment follow up population
  • had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period

Exclusion Criteria:

  • has any history of Type 1 diabetes mellitus or ketoacidosis
  • has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
  • has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
  • is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
  • has undergone surgery within 30 days prior to Visit 1 or has planned major surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    MK-0941 10 mg

    MK-0941 20 mg

    MK-0941 30 mg

    MK-0941 40 mg

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Hemoglobin A1c (HbA1c) Level
    Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
    Percentage of Participants Who Experienced at Least One Adverse Event
    Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event

    Secondary Outcome Measures

    Change in the Two-hour Post Meal Glucose Level
    Least squares mean change from baseline in 2-hour post meal glucose level.
    Change in the Fasting Plasma Glucose Level
    Least squares mean change from baseline in fasting plasma glucose.
    Percentage of Participants Who Achieve an HbA1c of <7.0%
    Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%

    Full Information

    First Posted
    October 3, 2008
    Last Updated
    February 2, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00767000
    Brief Title
    Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
    Official Title
    A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    June 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
    The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.
    Detailed Description
    This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.

    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 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    813 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-0941 10 mg
    Arm Type
    Experimental
    Arm Title
    MK-0941 20 mg
    Arm Type
    Experimental
    Arm Title
    MK-0941 30 mg
    Arm Type
    Experimental
    Arm Title
    MK-0941 40 mg
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MK-0941
    Intervention Description
    MK-0941 tablets three times daily
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Matching placebo to MK-0941 three times daily
    Intervention Type
    Biological
    Intervention Name(s)
    Lantus
    Other Intervention Name(s)
    Insulin glargine injection
    Intervention Description
    Lantus injection once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.
    Primary Outcome Measure Information:
    Title
    Change in Hemoglobin A1c (HbA1c) Level
    Description
    Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
    Time Frame
    Baseline and Weeks 14, 54, 106, and 158
    Title
    Percentage of Participants Who Experienced at Least One Adverse Event
    Time Frame
    Entire study including 54-week study and 104-week extension
    Title
    Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
    Time Frame
    Entire study including 54-week study and 104-week extension
    Secondary Outcome Measure Information:
    Title
    Change in the Two-hour Post Meal Glucose Level
    Description
    Least squares mean change from baseline in 2-hour post meal glucose level.
    Time Frame
    Baseline and Weeks 14, 54, 106, and 158
    Title
    Change in the Fasting Plasma Glucose Level
    Description
    Least squares mean change from baseline in fasting plasma glucose.
    Time Frame
    Baseline and Weeks 14, 54, 106, and 158
    Title
    Percentage of Participants Who Achieve an HbA1c of <7.0%
    Time Frame
    Weeks 106 and 158
    Title
    Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
    Time Frame
    Weeks 54, 106 and 158

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: has type 2 diabetes mellitus has body mass index >20 and <43 kg/m^2 is a male, or a female who is unlikely to conceive currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus Extension Study Inclusion Criteria: completed the base study either on double-blind study medication or as part of the post-treatment follow up population had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period Exclusion Criteria: has any history of Type 1 diabetes mellitus or ketoacidosis has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1 has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
    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
    21994424
    Citation
    Meininger GE, Scott R, Alba M, Shentu Y, Luo E, Amin H, Davies MJ, Kaufman KD, Goldstein BJ. Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. Diabetes Care. 2011 Dec;34(12):2560-6. doi: 10.2337/dc11-1200. Epub 2011 Oct 12.
    Results Reference
    result

    Learn more about this trial

    Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

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