An Investigational Drug Study to Assess Weight Loss in Patients With Type 2 Diabetes Mellitus

Verified by: Merck, October 2009
First Received: February 1, 2007 | Last Updated: October 12, 2009 | Phase: Phase 3 | Start Date: November 2006
Overall Status: Terminated | Estimated Enrollment: 600
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Arm 1: MK0364 0.5 mg capsule once daily
  • Experimental: 2
    • Arm 2: MK0364 1 mg capsule once daily
  • Experimental: 3
    • Arm 3: MK0364 2 mg capsule once daily
  • Placebo Comparator: 4
    • Arm 4: Pbo capsule once daily

Outcome Measures for this Clinical Trial

Primary Measures

  • Body weight at 36 weeks, HbA1c at 36 weeks
    • Time Frame: 36 weeks
      Safety Issue?: No

Secondary Measures

  • Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks
    • Time Frame: 24 and 52 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00430742

Study ID Number: 2006_021

ClinicalTrials.gov Identifier: NCT00430742

Health Authority: United States: Food and Drug Administration

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00430742