NCT05702073已完成3 期
A Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial Comparing the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Basal Insulin
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
- 423
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes≥ 6 months;
- •HbA1c 7.0% ~ 10.0% (Both inclusive) at screening;
- •Treated with Basal insulin ≥10U /day for at least 8 weeks prior to screening.
排除标准
- •Known or suspected allergy or intolerance to investigational medicinal products or related products.
- •Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- •Potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
- •Received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening.
- •Participated in clinical trials of any approved or unapproved investigational drug/treatment within the previous 1 month or 5 half-life period, whichever is longer, prior to screening.
- •Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential are reluctant to use appropriate contraception during the trial and for at least 14 days after the last dose of the investigational medicinal drug; Anycircumstances that the investigator judges might not be suitable to participate in the trial..
研究组 & 干预措施
INS068
Experimental
干预措施: INS068 injection (Drug)
IGlar
Active Comparator
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0 to Week 26
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
次要结局
- Incidence and rate of Hypoglycemic events(Week 0 to Week 26+14 days follow-up)
- Anti-drug Antibodies(Week 0 to Week26 + 14 days follow-up)
- Change in FPG(fasting plasma glucose)(Week 0 to Week 26)
- Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%(Week 0 to Week 26)
- per-breakfast SMPG(Week 0 to Week 26)
- Change in weight(Week 0 to Week 26)
- Serum INS068 concentration(Week 0 to Week 26)
- Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)(Week 0 to Week 26)
- 8-point SMPG profiles(Week 0 to Week 26)
- Average daily Insulin dose(Week 0 to Week 26)
- Proportion of Subjects requiring rescue therapy during treatment(Week 0 to Week 26)
- Frequency and severity of adverse events(Week 0 to Week26 +14 days follow-up)
研究者
研究点 (1)
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