NCT06199505已完成2 期
A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2023年11月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- •BMI = 18.5-35 kg/m2 (inclusive) at screening.
- •Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
- •7.0% ≤ HbA1c ≤ 11.0% at screening.
排除标准
- •Women in pregnancy or lactation.
- •Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
- •Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
- •Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
- •Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
- •Known or suspected hypersensitivity to trial product(s).
- •Participation in a clinical study of another study drug within 1 month prior to randomization.
研究组 & 干预措施
insulin degludec/insulin aspart,
Active Comparator
insulin degludec/insulin aspart injection s.c., once or twice daily, treat-to-target dose
干预措施: insulin degledec/insulin aspart (Drug)
GZR101
Experimental
GZR101 injection s.c., once daily, treat-to-target dose
干预措施: GZR101 (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Baseline to week 16
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
次要结局
- Change in Fasting Plasma Glucose (FPG)(Baseline to Week 16)
- Change from baseline in ADA and Nab(Baseline to Week 16)
- Incidence and Rate of Treatment-emergent AE/SAEs(Baseline to Week 16)
- The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16(Week 16)
- Incidence and Rate of hypoglycemia Events(Baseline to Week 16)
研究者
研究点 (1)
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