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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.
  Purpose
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.

Condition Intervention Phase
Obesity Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: Taranabant Drug: Comparator: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Body weight at 36 weeks, HbA1c at 36 weeks [ Time Frame: 36 weeks ]

Secondary Outcome Measures:
  • Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks [ Time Frame: 24 and 52 weeks ]

Enrollment: 600
Study Start Date: November 2006
Study Completion Date: November 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Arm 1: MK0364 0.5 mg capsule once daily
Drug: Taranabant
Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
Experimental: 2
Arm 2: MK0364 1 mg capsule once daily
Drug: Taranabant
Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
Experimental: 3
Arm 3: MK0364 2 mg capsule once daily
Drug: Taranabant
Taranabant 0.5 mg, 1 mg capsule, 2 mg capsule once daily Treatment for 52 weeks.
Placebo Comparator: 4
Arm 4: Pbo capsule once daily
Drug: Comparator: Placebo
Placebo capsule once daily. Treatment for 52 weeks.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430742


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00430742     History of Changes
Other Study ID Numbers: 0364-011
2006_021
First Submitted: February 1, 2007
First Posted: February 2, 2007
Last Update Posted: February 13, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases