NCT01386099已完成2 期
A Phase IIa Study to Build an Understanding of the Pharmacokinetic-Pharmacodynamic Relationship of PSN821 in Type 2 Diabetes Patients (T2DM).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Beta-cell function
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of PSN821 in patients with type 2 diabetes.
Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the start of treatment and at the end of a 12 week treatment period as the primary endpoint. HbA1c, fasting plasma glucose and body weight are secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Patients with Type 2 diabetes according to the American Diabetes Association criteria, diagnosed at least 12 months prior to screening.
- •Male or female, between 18 and 75 years of age, inclusive.
- •Body Mass Index of 25 - 45 kg/m2, inclusive.
- •Diabetes managed on a stable regimen of diet, exercise and metformin monotherapy (without dosage adjustments within 4 weeks prior to screening).
- •Haemoglobin A1c (HbA1c) of 7.5 10% at screening.
- •Fasting plasma glucose (FPG) of between 7 - 13.3 mmol/L at screening and Day -
- •Males who are, and whose partners are able to comply with contraceptive advice.
- •Females of non child-bearing potential.
- •Willing to sign the written Informed Consent Form (ICF) to participate in the study and to abide by the study restrictions.
排除标准
- •Patients with Type 1 diabetes or maturity onset diabetes of the young or secondary forms of diabetes, such as due to pancreatitis.
- •Marked diabetic complications.
- •Illness or medication that impacts on the scientific integrity of the study.
研究组 & 干预措施
PSN821
Experimental
干预措施: PSN821 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Beta-cell function
时间窗: 12 weeks
Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the start of treatment and at the end of a 12 week treatment period as the primary endpoint.
次要结局
- HbA1c(12 weeks)
- Fasting plasma glucose(12 weeks)
- Body weight(12 weeks)
研究者
研究点 (4)
Loading locations...
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