NCT05834868已完成3 期
A Phase 3, Randomized, Open-Label, Multicenter, Active-controlled Trial Comparing Efficacy and Safety of THDB0206 Injection With Insulin Lispro Injection Combined With Insulin Glargine Injection U-100 in Chinese Participants With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,040
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
研究概览
简要总结
This is a 26-week randomized, open-label, multicenter, active-controlled parallel group trial. The purpose of this study is to compare efficacy and safety of THDB0206 injection with insulin lispro injection combined with insulin glargine injection U-100 in Chinese participants with T2DM.
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
- •Body mass index: 18.0 kg/m^2~35.0 kg/m^2 (both inclusive) at the time of screening.
- •HbA1c: 7.0%~10.0% (both inclusive) at the time of screening.
- •Diagnosed with T2DM for 6 months or longer at the time of screening based on the World Health Organization (WHO) classification.
- •Treated with stable insulin regimen as follow for at least 3 months with or without oral antidiabetic drug:
- •Basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine, insulin degludec, insulin detemir) in combination with at least 1 prandial injection of bolus insulin.
- •Premixed insulin at least twice daily.
排除标准
- •Have other types of diabetes other than T2DM.
- •Have used Glucagon-Like Peptide 1 (GLP-1) receptor agonist within 3 months prior to screening.
- •Have had 1 or more episodes of severe hypoglycemia within the 6 months prior to screening.
- •Have had 1 or more episodes of acute diabetic complications (diabetic ketoacidosis, hyperglycemic hyperosmolar state, diabetic lactic acidosis, etc.) within the 6 months prior to screening.
- •With concomitant conditions at screening that may affect the evaluation of the study, including cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, liver diseases, kidney diseases, nervous system diseases, psychiatric diseases, hematological diseases, immune system diseases, endocrine system diseases, pancreatic diseases, and/or malignant tumors.
研究组 & 干预措施
THDB0206 Injection
Experimental
干预措施: THDB0206 Injection (Drug)
Insulin Lispro Injection
Active Comparator
干预措施: Insulin Lispro Injection (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
时间窗: Week 26
次要结局
- Change From Baseline in 1-hour Postprandial Glucose (PPG) Excursion at Week 26(Week 26)
- Change From Baseline in 2-hour Postprandial Glucose (PPG) Excursion at Week 26(Week 26)
研究者
研究点 (1)
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