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

This study has been terminated.
(The overall profile does not support development for obesity)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430742
First Posted: February 2, 2007
Last Update Posted: February 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
February 1, 2007
February 2, 2007
February 13, 2015
November 2006
January 2008   (Final data collection date for primary outcome measure)
Body weight at 36 weeks, HbA1c at 36 weeks [ Time Frame: 36 weeks ]
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Complete list of historical versions of study NCT00430742 on ClinicalTrials.gov Archive Site
Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks [ Time Frame: 24 and 52 weeks ]
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Not Provided
Not Provided
 
An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus (0364-011)(TERMINATED)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Obesity Type 2 Diabetes Mellitus
  • Type 2 Diabetes Mellitus
  • Drug: Taranabant
    Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
  • Drug: Comparator: Placebo
    Placebo capsule once daily. Treatment for 52 weeks.
  • Experimental: 1
    Arm 1: MK0364 0.5 mg capsule once daily
    Intervention: Drug: Taranabant
  • Experimental: 2
    Arm 2: MK0364 1 mg capsule once daily
    Intervention: Drug: Taranabant
  • Experimental: 3
    Arm 3: MK0364 2 mg capsule once daily
    Intervention: Drug: Taranabant
  • Placebo Comparator: 4
    Arm 4: Pbo capsule once daily
    Intervention: Drug: Comparator: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
November 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   India,   Lithuania,   Malaysia,   Peru,   Philippines,   Poland,   Russian Federation,   Sweden,   Taiwan,   United States
 
NCT00430742
0364-011
2006_021
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP