NCT07242664招募中1 期
A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared With Insulin Degludec at Steady State in Participants With Type 1 Diabetes
Gan and Lee Pharmaceuticals, USA2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年10月13日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- the relative potency of GZR33 to insulin degludec
研究概览
简要总结
This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR33 (hereafter referred to as GZR33) and estimate its potency in comparison with insulin degludec.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes for at least 12 months
- •18-64 years of age
- •HbA1c <= 9.0%.
- •Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2
- •treated with a stable insulin regimen for at least 2 months, in a dose > 0.2 and < 1.2 U/kg/day
排除标准
- •blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic)
- •clinically significant concomitant diseases
- •recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening)
- •hypoglycemia unawareness
- •estimated glomerular filtration rate (eGFR) <60.0 mL/min/1.73 m2
研究组 & 干预措施
Period 1 - GZR-33, period 2 insulin degludec
Experimental
Period 1 - GZR-33 once daily for six days. Post wash-out, insulin degludec once daily for six days
干预措施: GZR-33 (Drug)
Period 1 - insulin degludec, period 2 - GZR-33
Experimental
Period 1 - insulin degludec once daily for six days. Post wash-out, GZR-33 once daily for six days
干预措施: GZR-33 (Drug)
结局指标
主要结局
the relative potency of GZR33 to insulin degludec
时间窗: a two week run-in phase
Primary endpoint will be the relative potency of GZR33 to insulin degludec, according to the following equation: Relative Potency = GIR24h,ss,GZR33 /GIR24h,ss,degludec) × (Dosedegludec/DoseGZR33).
次要结局
未报告次要终点
研究者
研究点 (2)
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