Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial to investigate tolerability, safety, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SCO-094 subcutaneously administered in patients with type 2 diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- proportion of patients with clinically significant changes in laboratory safety tests
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial
- 主要目的
- Other
入排标准
- 年龄范围
- 18age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Type 2 diabetic Caucasian male or females will be included if they are aged between 18 and 65 (inclusive), with a body mass index (BMI) between 18.0 and 35.0 kg/m
- •Patients must be stable and treated with either diet and exercise alone or an anti-glycaemic monotherapy (metformin, DPP-4i, pioglitazone, an SU or an SGLT-2i). Patients must agree to use effective methods of contraception.
排除标准
- •Patients treated with insulin such as type 1 diabetes or evidence of C-peptide deficiency and patients with
- •current or recurrent disease; e.g., cardiovascular, haematological, neurological, endocrine, immunological, renal, hepatic or gastrointestinal or other conditions)
- •that could affect the action, absorption, or disposition of SCO-094, or could affect clinical assessments or clinical laboratory evaluations.
结局指标
主要结局
proportion of patients with clinically significant changes in laboratory safety tests
The safety and tolerability of SCO-094 as measured by the proportion of patients with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation, and urinalysis).
incidence of treatment emergent adverse events (TEAEs)
The safety and tolerability of SCO-094 as measured by the incidence of treatment emergent adverse events (TEAEs).
proportion of patients with morphological and/or rhythm abnormalities on electrocardiogram (ECG)
The safety and tolerability of SCO-094 as measured by the proportion of patients with morphological and/or rhythm abnormalities on electrocardiogram (ECG).
proportion of patients with clinically significant changes in ECG time intervals
The safety and tolerability of SCO-094 as measured by the proportion of patients with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals).
proportion of patients with clinically significant changes in vital signs
The safety and tolerability of SCO-094 as measured by the proportion of patients with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation and body temperature).
次要结局
未报告次要终点