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 Extension

Merck Sharp & Dohme (Sweden) AB0 个研究点目标入组 600 人开始时间: 2006年10月31日最近更新: 2012年3月19日

研究概览

暂无简介。

•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

•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

发起方

Merck Sharp & Dohme (Sweden) AB