NCT06553248已完成1 期
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of GZR4 in Chinese Patients With Type 2 Diabetes Mellitus
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年3月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Incidence of TEAE
研究概览
简要总结
This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at the age of 18-65 (inclusive) at the time of informed consent
- •Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
- •Diagnosis of type 2 diabetes mellitus for over 3 months
- •Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.
排除标准
- •History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
- •Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
- •Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
- •Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
- •Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms
研究组 & 干预措施
GZR4
Experimental
s.c., once weekly
干预措施: GZR4 (Drug)
Insulin Degludec
Active Comparator
s.c., once daily
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Incidence of TEAE
时间窗: Baseline to Week 6
次要结局
- AUC0-inf(Week 6)
- AUC0-168h(Week 1, Week 6)
- ADA of GZR4(Baseline to Week 10)
- AUC0-last(Week 6)
- Tmax,GZR4(Week 1, Week 6)
研究者
研究点 (1)
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