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

Phase 3

Terminated

• Conditions: Obesity Type 2 Diabetes Mellitus; Type 2 Diabetes Mellitus
• Interventions: Drug: Taranabant

• Registration Number: NCT00430742
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2008-01
• Study Completion: 2008-11
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-12
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Taranabant	Arm 2: MK0364 1 mg capsule once daily
1	Taranabant	Arm 1: MK0364 0.5 mg capsule once daily
3	Taranabant	Arm 3: MK0364 2 mg capsule once daily

Primary Outcome Measures

Name	Time	Method
Body weight at 36 weeks, HbA1c at 36 weeks	36 weeks

Secondary Outcome Measures

Name	Time	Method
Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks	24 and 52 weeks