A Phase IIb/III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK-0364) in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM) Followed by a 1-Year Extension - MK-0364: One-Year Weight-Loss in Overweight and Obese Patients with T2DM with 1-Year Extensio

• Conditions: Obesity in patients with type 2 diabetes mellitus; MedDRA version: 8.1Level: LLTClassification code 10029883Term: Obesity

• Registration Number: EUCTR2006-002544-28-SE
• Lead Sponsor: Merck Sharp & Dohme (Sweden) AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Men (minimum 25%; targeting 40%) and women with a body mass index (BMI) between 27 kg/m2 and 43 kg/m2, inclusive.
2. Patients =18 and 3. Patients will have an HbA1c between 7.0% and 10.0%, inclusive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has a history of type 1 diabetes mellitus [confirmed with a C-peptide <0.8 ng/mL (0.26 nmol/L)] or a history of ketoacidosis.

2. Patient has a history or presence of a major psychiatric disorder including, but not limited to schizophrenia or other psychotic disorders, major depression, bipolar disorder, generalized anxiety disorder, personality disorder or eating disorder (e.g. bulimia, anorexia disorder).

3. Patient has a history of seizures or is at high risk of developing seizures (e.g., those with history of brain tumors or severe head trauma or intracranial hemorrhage).
4. Patient currently uses or is likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP3A4, or currently uses or plans to use any medication in the medication exclusion list

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified