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
About this trial
This is an interventional treatment trial for Obesity Type 2 Diabetes Mellitus
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
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
NCT ID
NCT00430742
First Posted
February 1, 2007
Last Updated
February 12, 2015
Sponsor
Merck Sharp & Dohme LLC
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
result
Learn more about this trial
An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)
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