NCT07070752已完成3 期
Multicenter, Open-Label, Randomized, Controlled Study of Non-Inferior Immunogenicity of GP40321 (Solution for Subcutaneous Injection, 100 U/mL; GEROPHARM LLC, Russia) and Apidra® SoloStar® (Solution for Subcutaneous Injection, 100 U/mL; Sanofi-Aventis Deutschland GmbH, Germany) in Type 1 Diabetes Mellitus Patients
Geropharm16 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2023年4月14日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 16
- 主要终点
- Proportion of patients who develop an immune response
研究概览
简要总结
The goal of this clinical trial is to demonstrate the non-inferior immunogenicity of GP40321 compared to Apidra® SoloStar® at a concentration of 100 U/mL in type 1 diabetes mellitus patients. The main questions it aims to answer are:
- What is the immunogenicity of GP40321 and Apidra® SoloStar®?
- What are the efficacy and safety of GP40321 and Apidra® SoloStar®?
Researchers will compare the immunogenicity, efficacy and safety parameters of GP40321 and Apidra® SoloStar®.
Participants will:
• Visit the clinic 9 times: once for screening, 3 times during dose titration (plus 2 telephone contacts) and 5 times during the stable dose treatment period.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GP40321
Experimental
干预措施: GP40321 (Drug)
GP40321
Experimental
干预措施: RinGlar® (Drug)
Apidra® SoloStar®
Active Comparator
干预措施: Apidra® SoloStar® (Drug)
Apidra® SoloStar®
Active Comparator
干预措施: RinGlar® (Drug)
结局指标
主要结局
Proportion of patients who develop an immune response
时间窗: From screening to the end of treatment at Week 26
The proportion of patients who develop an immune response during the study.
次要结局
- Change in mean anti-insulin antibodies (AIA) level(From screening to the end of treatment at Week 26)
- Change in mean neutralizing anti-insulin antibodies (nAIA) level(From screening to the end of treatment at Week 26)
- Incidence of nAIA in nAIA-naïve subjects(From screening to the end of treatment at Week 26)
- Proportion of patients with clinically significant immune response(From screening to the end of treatment at Week 26)
- Change in mean HbA1c level(From screening to the end of treatment at Week 26)
- Proportion of patients with HbA1c ≤7.0%(From screening to the end of treatment at Week 26)
- Proportion of patients with reached individual target HbA1c(From screening to the end of treatment at Week 26)
- Change in mean fasting plasma glucose (FPG)(From screening to the end of treatment at Week 26)
- Change in mean values of the 7-point glycemic profile(From the end of the dose titration period to the end of treatment at Week 26)
- Change in mean total daily insulin dose(From the end of the dose titration period to the end of treatment at Week 26)
- Change in mean body weight(From screening to the end of treatment at Week 26)
- Treatment satisfaction(From screening to the end of treatment at Week 26)
- Assessment of safety(From screening to the end of treatment at Week 26)
研究者
研究点 (16)
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