A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of SCO-792 in Subjects with Obese Type 2 Diabetes Mellitus on Metformin Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AE)
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
- A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 65age old under（—）
- 性别
- All
入选标准
- •The subject signs and dates a written, informed consent form prior to the initiation of any study procedures.
- •The subject is capable of understanding and complying with protocol requirements.
- •The subject is either male or female and aged 18 to 65 years (inclusive) at signing of informed consent.
- •The subject has been treated with stable doses of metformin monotherapy (>=1000 mg/day) for at least 3 months prior to Visit 1 as determined by subject report.
- •The subject has a HbA1c >=7.0% (>=53 mmol/mol) and <10.5% (<=91 mmol/mol) as assessed by the central laboratory at Visit 1 and Visit
- •The subject has a body mass index >=30kg/m2 as assessed by the study site at Visit 1 and Visit 2.
排除标准
- •1.The subject has a history of type 1 diabetes mellitus or a history of ketoacidosis;
- •2.The subject has a history of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant);
结局指标
主要结局
Incidence and severity of adverse events (AE)
Incidence and severity of adverse events (AE)
Incidence of serious adverse events
Incidence of serious adverse events
Clinically significant changes from baseline in clinical laboratory tests
Clinically significant changes from baseline in clinical laboratory tests
Clinically significant changes from baseline in 12-lead electrocardiograms
Clinically significant changes from baseline in 12-lead electrocardiograms
Clinically significant changes from baseline in vital signs
Clinically significant changes from baseline in vital signs
Clinically significant changes from baseline in physical examinations
Clinically significant changes from baseline in physical examinations
Incidence and severity of hypoglycemia and hyperglycemia
Incidence and severity of hypoglycemia and hyperglycemia
Change in HbA1c value from baseline at the completion of the treatment period
时间窗: Week 12
Change in HbA1c value from baseline at the completion of the treatment period
次要结局
- Change in fasting plasma glucose value from baseline(Week 12)
- Percent change in body weight value from baseline(Week 12)