NCT04023344已完成3 期
An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Insulin Lispro Biphasic 25 ("Geropharm", Russia) Humalog® Mix 25 ("Lilly France", France) in Type 2 Diabetes Mellitus Patients
Geropharm18 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2018年3月14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
- 210
- 试验地点
- 18
- 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 Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.
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
- •Clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
- •Glycosylated hemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive)
- •Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive)
- •Stable doses OADs for at least 3 months prior to treatment of experimental drug
- •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
- •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.)
- •Contraindication to the use of insulin Lispro Biphasic 25
- •Insulin resistance over 1.5 U/kg insulin pro day
- •Presence of insulin antibodies in the blood at the screening ˃10 U/ml
- •Use of 3 or more oral antidiabetic drugs (OAD)
- •Presence of severe diabetes complications
- •History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
- •Deviation of vital signs, which can influence to results
- •History of administration of glucocorticoids for 1 year prior to screening
- •History of autoimmune disease, except controlled autoimmune thyroid disease
- •Pregnant and breast-feeding women
- •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
- •Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexatum)
- •Incomplete recovery after surgery procedure
研究组 & 干预措施
Humalog® Mix 25
Active Comparator
Insulin Humalog® Mix 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
干预措施: Humalog Mix25 (Drug)
Insulin Lispro Biphasic 25
Experimental
Insulin Lispro Biphasic 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
干预措施: Insulin Lispro Biphasic 25 (Drug)
结局指标
主要结局
Antibody Response
时间窗: 26 weeks
Change from baseline in titer of antibodies to human insulin
次要结局
- Treatment Satisfaction(26 weeks)
- Adverse Events frequency and degree(26 weeks (4+22 weeks))
- Fasting Plasma Glucose Level(26 weeks)
- Seven-Point Glucose Testing(26 weeks)
- HbA1c(26 weeks)
- Body Mass Index(26 weeks)
- Insulin Dose(26 weeks)
研究者
研究点 (18)
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