NCT04079413已完成3 期
An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO "GEROPHARM", Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients
Geropharm14 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2019年6月3日最近更新:
适应症
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
- 264
- 试验地点
- 14
- 主要终点
- Immunogenicity
研究概览
简要总结
This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written consent
- •Diabetes mellitus type 1 for at least 12 months prior to screening
- •History of basis-bolus (multiple dose injection (MDI)) therapy in stable doses at least 30 days
- •Glycated hemoglobin (HbA1c) level of 7.1 to 12.0 % at screening (both values inclusive)
- •Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive)
- •Subject is able and willing to comply with the requirements of the study protocol
排除标准
- •Contraindication to the use of insulin aspart
- •Insulin resistance over 1.5 U/kg insulin pro day
- •Change INN of insulin for 6 months prior to randomisation
- •History of treatment any biosimilar insulin for 6 months prior to randomisation (excl. GEROPHARM's insulins)
- •History of treatment any experimental drugs or medical devices for 3 months prior to randomisation
- •History of treatment insulin pump for 180 days prior to signed written consent or indication for use insulin pump
- •Presence of severe diabetes complications
- •History of severe hypoglycemia for 6 months prior to screening
- •History of 15 or more episodes mild hypoglycemia for 1 month prior to screening
- •History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
- •History of administration of glucocorticoids (14 days or more) for 1 year prior to screening
- •Administration of any immunosuppressive drugs (Cyclosporine, Methotrexate, Rituximab, etc.)
- •History of vaccination for 6 months prior to randomisation
- •History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency
- •History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year prior to screening
- •History of stroke or TIA for 6 months prior to screening
- •History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions
- •Pregnant and breast-feeding women
- •Acute inflammation disease for 3 weeks prior to screening
- •Deviation of the laboratory results conducted during the screening:
- •Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value
- •History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.)
- •Serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.)
- •Incomplete recovery after surgery procedure
- •History of drug, alcohol abuse for 3 years prior to screening
- •Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at screening
- •History of oncological disease during 5 years prior to screening
- •History of transplantation, except 3 months after corneal transplant
- •History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
- •Inability follow to protocol
研究组 & 干预措施
GP40071
Experimental
Subcutaneous (SC), before meals intake, up to Week 26
干预措施: GP40071 (Drug)
NovoRapid® Penfill®
Active Comparator
Subcutaneous (SC), before meals intake, up to Week 26
干预措施: NovoRapid® Penfill® (Drug)
结局指标
主要结局
Immunogenicity
时间窗: 26 weeks
Change from baseline in titer of antibodies to human insulin
次要结局
- Adverse Events frequency and degree(26 weeks)
- Achievement of Glycated Hemoglobin Goals(26 weeks)
- Achievement of Glycated Hemoglobin < 7%(26 weeks)
- Glycated hemoglobin(26 weeks)
- Treatment Satisfaction(26 weeks)
- Body Mass Index(26 weeks)
- Fasting Plasma Glucose Level(26 weeks)
- Seven-Point Glucose Testing(26 weeks)
- Total Insulin Dose(26 weeks)
研究者
研究点 (14)
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