Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Safety measurements
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of the Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc) doses in patients with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent prior to any study specific procedures
- •Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months
- •Male or female patient aged 18 to 75 years at screening, both inclusive
- •BMI >22 to ≤40 kg/m2 at screening
排除标准
- •Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly
- •Fasting C-peptide < 500 pM at screening
- •Acute gastrointestinal symptoms at the time of screening and/or Day -1
- •Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis
研究组 & 干预措施
CM3.1-AC100 dose A
Compound CM3.1-AC100 s.c.
干预措施: CM3.1-AC100 (Drug)
CM3.1-AC100 dose B
Compound CM3.1-AC100 s.c.
干预措施: CM3.1-AC100 (Drug)
CM3.1-AC100 dose C
Compound CM3.1-AC100 s.c.
干预措施: CM3.1-AC100 (Drug)
Placebo
Placebo for compound CM3.1-AC100 s.c.
干预措施: CM3.1-AC100 (Drug)
结局指标
主要结局
Safety measurements
时间窗: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
AEs, ECGs, BP, pulse, body temperature, laboratory variables, local tolerability including a VAS score for local pain, Present Nausea Intensity (PNI) by a nausea questionnaire and a VAS score of the Overall Nausea Index (ONI)
次要结局
- PK samples for CM3.1-AC100(Intense PK-sampling during the 24 hours following administration of CM3.1-AC100)