NCT04226105Unknown3 期
An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40081 (OOO "GEROPHARM", Russia) Compared to NovoMix® 30 FlexPen® (Novo Nordisk A/S, Denmark) in Type 2 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: 2020年1月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 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 T2DM comparing the efficacy and safety of GP40081 (insulin asapart mix 30, GEROPHARM) with that of NovoMix® 30 FlexPen®.
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 2 for at least 6 months before the screening (WHO criteria 1999-2013).
- •Glycated haemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive).
- •Indications for exogenous insulin therapy.
- •Body mass index (BMI) of 18.5 to 40 kg/m2 at screening (both values inclusive).
- •Insulin-naive patients or prior insulin therapy at least 6 months before randomization.
- •The 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 30 mix.
- •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 severe hypoglycemia for 6 months before the screening.
- •History of severe hyperglycemia for 6 months before the screening.
- •Bariatric surgery for 12 months to screening.
- •Glucagon-like peptide-1 (GLP-1)-based therapies for 8 weeks to screening.
- •Insulin resistance over 1.5 U/kg insulin pro day.
- •Change INN of insulin for 6 months before the randomisation.
- •History of treatment any experimental drugs or medical devices for 3 months before the randomisation.
- •Presence of severe diabetes complications.
- •Night work.
- •History of administration of glucocorticoids (14 days or more) for 1 year before the screening.
- •Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexate, Rituximab, etc.).
- •History of vaccination for 6 months before the randomisation.
- •History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except vetiligo and Hashimoto's thyroiditis.
- •Pregnant and breast-feeding women.
- •Deviation of the laboratory results conducted during the screening: Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds or ALT or AST value > 3 folds as high as maximal normal value; Serum bilirubin value > 2 folds as high as maximal normal value (except Gilbert's syndrome).
- •History of haematological disorders that can affect the reliability of HbA1c estimation (haemoglobinopathies, hemolytic anaemia, etc.).
- •Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at the screening.
- •Acute inflammation disease for 3 weeks before the screening.
- •History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year before the screening.
- •History of stroke or TIA for 6 months before the screening.
- •Serious blood loss for 3 months before the screening (blood donation, surgery procedure, etc.).
- •The inability of the patient to assess their condition because of mental or physical disorders.
- •History of drug, alcohol abuse for 3 years before the screening.
- •History of oncology disorders for 5 years before the screening.
- •History of transplantation, except 3 months after a 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
研究组 & 干预措施
GP40081
Experimental
Subcutaneous (SC), up to Week 26
干预措施: GP40081 (Drug)
NovoMix® 30 FlexPen®
Active Comparator
Subcutaneous (SC), up to Week 26
干预措施: NovoMix 30 (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
- Fasting Plasma Glucose Level(26 weeks)
- Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire(26 weeks)
- Total Insulin Dose(22 weeks)
- Achievement of Glycated Hemoglobin < 7%(26 weeks)
- Seven-Point Glucose Testing(22 weeks)
- Glycated hemoglobin(26 weeks)
- Adverse Events frequency and degree(26 weeks)
- Body Mass Index(26 weeks)
- Achievement of Glycated Hemoglobin Goals(26 weeks)
研究者
研究点 (14)
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