NCT04012775已完成3 期
An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients
Geropharm28 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2017年4月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 28
- 主要终点
- Antibody Response
研究概览
简要总结
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.
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
- •Signed written consent
- •Diabetes mellitus type 2
- •Indications for Rinsulin NPH / Humalog NPH treatment
- •Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
- •Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).
- •Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion.
排除标准
- •Age less than 18 years old at screening
- •Pregnant and breast-feeding women
- •Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
- •Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
- •Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at 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.
- •History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.).
- •History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
- •Presence of severe diabetes complications
- •Receipt of another investigational drug in the 3 months prior to screening
- •Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening
- •History or presence of drug abuse
- •Positive test for addictive substance in urine at screening
研究组 & 干预措施
Insulin Humulin® NPH
Active Comparator
Insulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment
干预措施: Insulin Humulin® NPH (Biological)
Insulin Rinsulin® NPH
Experimental
Insulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment
干预措施: Insulin Rinsulin® NPH (Biological)
结局指标
主要结局
Antibody Response
时间窗: 24 weeks
Change from baseline in titer of antibodies to human insulin
次要结局
- Occurrence of adverse events(28 weeks (4 + 24 weeks))
- Change in basal insulin dose per body weight (U/kg) from baseline(24 weeks)
- Change in total basal insulin dose (U) from baseline(24 weeks)
- Change in fasting plasma glucose level from baseline(28 weeks)
- Change in BMI from baseline(24 weeks)
- Occurrence of Injection Site Reaction(28 weeks (4 + 24 weeks))
- Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency(28 weeks (4 + 24 weeks))
- Change in HbA1c from baseline(24 weeks)
研究者
研究点 (28)
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