A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of RinGlar® (LLC "GEROPHARM", Russia) Versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients Using the Euglycemic Clamp Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- AUC GIR(0-t)
研究概览
简要总结
Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis)
详细描述
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of RinGlar® (LLC "GEROPHARM", Russia) versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients using the euglycemic clamp technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study was blinded for Sponsor, investigators and analytical laboratory
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Caucasian males having confirmed diabetes mellitus type 1 (WHO criteria) for at least 12 months prior to screening.
- •Age of 18-65 (both incl.).
- •HbA1С ≤ 8,0 %.
- •Insulin therapy in stable doses at least 3 months. Total dose of insulin ≤ 1,2 IU/kg per day.
- •At least 6 months of Lantus use.
- •C-peptide ≤ 0,3 nM/L (or 0,5 ng/mL).
- •Body mass index equal to 18.5-32.0 kg/m
- •Subject must use, with their partner, methods of highly effective contraception throughout the study.
- •Subject is able and willing to comply with the requirements of the study protocol.
排除标准
- •Acute inflammatory diseases within 3 weeks before the screening period.
- •History or presence of uncontrolled diabetes mellitus for 6 months prior to screening.
- •Clinically significant diabetes mellitus complications (proliferative retinopathy, severe diabetic neuropathy, diabetic nephropathy (CKD-EPI < 60 mL/min/1,73 m2), diabetic foot).
- •Clinically significant deviations in basic vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG and lab tests.
- •Deep vein thrombosis of lower extremities in a history of life or in a family history.
- •Taking medications (excl. insulin and ACE-inhibitors), phytopreparations, biologically active supplements less than 14 days before screening.
- •Donor blood donation or another blood loss, less than 3 months before the study.
- •Recovery after surgery process.
- •Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol, including psychiatric disorders.
- •History of significant drugs abuse conditions for 3 years prior to screening.
- •Positive testing for drugs.
- •Receiving more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of strong alcohol) or anamnestic information about alcoholism.
- •Positive testing for alcohol.
- •Nicotine dependence (use of tobacco less than 6 months before the start of screening).
- •Positive test results for hepatitis C or hepatitis B, HIV, syphilis.
- •Presence of suspicions of an inflammatory disease of the urinary system as a result of urinalysis.
- •Weighed allergic anamnesis.
- •Presence of oncology disease in the anamnesis 5 years prior the start of screening.
- •Organ transplantation in anamnesis (excl. cornea transplantation at least 3 month prior the IP administration).
- •Participation in a clinical trial of any medications less than 3 months before the IP administration.
- •Any other conditions that make it difficult, according to the informed opinion of the investigating physician, that volunteer participation in studies.
- •History of hypersensitivity to insulin, heparin and excipients of the drugs using in study.
研究组 & 干预措施
Lantus®
Single subcutaneous administration of Lantus® in dose 0.6 Units/kg
干预措施: Lantus® (Drug)
RinGlar®
Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg
干预措施: RinGlar® (Drug)
结局指标
主要结局
AUC GIR(0-t)
时间窗: 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose
Pharmacodynamic of insulin glargine by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
AUC(0-t)
时间窗: -60, -30 and 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose
Pharmacokinetics of insulin glargine by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
次要结局
未报告次要终点