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

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ClinicalTrials.gov Identifier: NCT00430742
Recruitment Status : Terminated (The overall profile does not support development for obesity)
First Posted : February 2, 2007
Last Update Posted : February 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus Drug: Taranabant Drug: Comparator: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
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
Study Start Date : November 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00430742     History of Changes
Other Study ID Numbers: 0364-011
2006_021
First Posted: February 2, 2007    Key Record Dates
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