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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00430742
First received: February 1, 2007
Last updated: March 13, 2014
Last verified: March 2014

February 1, 2007
March 13, 2014
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00430742
0364-011, 2006_021
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

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