A Phase II Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection and GZR33-70 Injection in Type 2 Diabetes Inadequately Controlled on Basal Insulin or Premixed Insulin Once Daily at Least With or Without Pre-dinner Meal-time Insulin
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 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, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.
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
- •Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
- •2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- •3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
- •4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.
排除标准
- •1.Presence or history of malignant neoplasm prior to screening.
- •2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
- •3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
- •4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
- •Participated in another interventional clinical study within 4 weeks prior to randomization.
研究组 & 干预措施
GZR101 Injection
Participants will receive once daily GZR101 Injection with or without pre-dinner meal-time insulin, s.c, treat-to-target dose
干预措施: GZR101 Injection (Drug)
GZR33-70 Injection
Participants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose
干预措施: GZR33 Injection (Drug)
GZR33-70 Injection
Participants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose
干预措施: Insulin aspart (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0, week 16
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
次要结局
- Change in 7-point SMPG profile(Week 0, Week 16)
- Incidence and Rate of Treatment-emergent AE/SAEs(Week 0, Week 19)
- Incidence and Rate of hypoglycemia Events(Week 0, Week 19)
- Change in Fasting Plasma Glucose (FPG)(Week 0, Week 16)