EUCTR2010-023231-42-IT进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, Phase 2b study of LY2409021 in patients with type 2 diabetes mellitus - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ELI LILLY
- 入组人数
- 260
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
- •Male or female patients not of child-bearing potential with type 2 diabetes mellitus (T2DM) between 18 and 70
- •years old, inclusive, treated with diet and exercise alone or in combination with metformin (at least 1000 mg/day
- •stable and unchanged for at least 3 months prior to screening) are eligible for this study.
- •Other criteria for inclusion include:
- •? HbA1c value between 7.0% and 10.5%, inclusive
- •? body mass index (BMI) between 25 to 45 kg/m2, 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
- •Main criteria for exclusion include:
- •? clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase
- •[AST] or alanine aminotransferase [ALT]) >2.5 times upper limit of normal (ULN) as determined by the
- •central laboratory at screening
- •? current or previous diagnosis of Gilbert’s disease
- •? previous diagnosis of hepatitis B or a current positive hepatitis B surface antigen, even if LFTs are <2.5
- •? previous diagnosis of hepatitis C or a current positive hepatitis C surface viral antibody, even if LFTs are
- •<2.5 times ULN
研究者
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