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An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)

Primary Purpose

Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Taranabant
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body Mass Index (BMI) between 27 kg/m2 and 43 kg/m2 and HbA1c between 7.0% and 10%

Exclusion Criteria:

  • History of major psychiatric disorder
  • Blood pressure greater than 160/100
  • Use of any antihyperglycemic agent other than metformin
  • Triglycerides greater then 600 mg/dL

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Arm 1: MK0364 0.5 mg capsule once daily

    Arm 2: MK0364 1 mg capsule once daily

    Arm 3: MK0364 2 mg capsule once daily

    Arm 4: Pbo capsule once daily

    Outcomes

    Primary Outcome Measures

    Body weight at 36 weeks, HbA1c at 36 weeks

    Secondary Outcome Measures

    Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks

    Full Information

    First Posted
    February 1, 2007
    Last Updated
    February 12, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00430742
    Brief Title
    An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)
    Official Title
    A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM) Followed by a 1-Year Extension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    The overall profile does not support development for obesity
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    November 2008 (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 worldwide study with extension in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug for weight loss on body weight.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Arm 1: MK0364 0.5 mg capsule once daily
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Arm 2: MK0364 1 mg capsule once daily
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Arm 3: MK0364 2 mg capsule once daily
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Arm Description
    Arm 4: Pbo capsule once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Taranabant
    Intervention Description
    Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo capsule once daily. Treatment for 52 weeks.
    Primary Outcome Measure Information:
    Title
    Body weight at 36 weeks, HbA1c at 36 weeks
    Time Frame
    36 weeks
    Secondary Outcome Measure Information:
    Title
    Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks
    Time Frame
    24 and 52 weeks

    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: Body Mass Index (BMI) between 27 kg/m2 and 43 kg/m2 and HbA1c between 7.0% and 10% Exclusion Criteria: History of major psychiatric disorder Blood pressure greater than 160/100 Use of any antihyperglycemic agent other than metformin Triglycerides greater then 600 mg/dL
    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
    20518807
    Citation
    Kipnes MS, Hollander P, Fujioka K, Gantz I, Seck T, Erondu N, Shentu Y, Lu K, Suryawanshi S, Chou M, Johnson-Levonas AO, Heymsfield SB, Shapiro D, Kaufman KD, Amatruda JM. A one-year study to assess the safety and efficacy of the CB1R inverse agonist taranabant in overweight and obese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Jun;12(6):517-31. doi: 10.1111/j.1463-1326.2009.01188.x.
    Results Reference
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    An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)

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