EUCTR2006-002544-28-DE进行中（未招募）1 期
A Phase IIb/III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM) - MK-0364: One-Year Weight-Loss in Overweight and Obese Patients with T2DM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 675
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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