NCT04236895已完成1 期
A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Glargine Injection (Insulin Glargine 100 U/mL) With US and EU Lantus® Comparator Products in Patients With Type 1 Diabetes Mellitus
Gan and Lee Pharmaceuticals, USA2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2018年7月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- PD endpoint
研究概览
简要总结
Primary objectives:
To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins.
max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes
To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan & Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes
Secondary objectives:
To compare the pharmacokinetic and pharmacodynamic properties of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)
To assess the safety and tolerability of Gan & Lee Insulin Glargine and of Lantus® (US RLD / EU RP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
- •Male subjects with type 1 diabetes mellitus for at least 12 months prior to screening as diagnosed clinically.
- •Age between 18 and 64 years, both inclusive.
- •Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive.
- •HbA1c <= 9.0%.
- •Fasting negative C-peptide (<= 0.30 nmol/L).
- •Total insulin dose of < 1.2 (I)U/kg/day.
- •Stable insulin regimen for at least 2 months prior to screening (with respect to safety of the subject and scientific integrity of the trial).
- •Considered generally healthy (apart from type 1 diabetes mellitus) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator
排除标准
- •Known or suspected hypersensitivity to IMPs or related products
- •Previous participation in this trial. Participation is defined as randomized
- •Receipt of any medicinal product in clinical development within 30 days or 5 half-lives (whichever is longer) before randomization in this trial
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator
- •Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), or signs of acute illness, as judged by the Investigator
- •Proliferative retinopathy or maculopathy (based on a recent (<1.5 years) ophthalmologic examination) and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- •Recurrent severe hypoglycemia (more than 1 severe hypoglycemic event during the past 6 months) or hypoglycemic unawareness as judged by the Investigator
- •Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
- •Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 24 grams alcohol/day
- •Symptomatic hypotension or supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-140 mmHg for systolic or greater than 90 mmHg for diastolic pressure
- •Heart rate at rest outside the range of 50-90 beats per minute
- •Clinically significant abnormal standard 12-lead ECG after 5 minutes resting in supine position at screening, as judged by the Investigator
- •A positive result in the alcohol and/or urine drug screen at the screening visit
- •Not able or willing to refrain from smoking and use of nicotine substitute products one day before and during the inpatient period
- •Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
- •Any medication (prescription and non-prescription drugs) within 14 days before IMP administration, with the exception of occasional use of Paracetamol or NSAIDs
- •Blood donation or blood loss of more than 500 mL within the last 3 months
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- •Fertile male with female partner(s) without using a highly effective contraceptive method in combination with spermicide-coated condoms from the first dosing until 1 month after dosing
研究组 & 干预措施
Lantus ® US
Active Comparator
Insulin glargine (Lantus®, product approved and marketed in the USA (US RLD)), 100 U/mL in 3 mL pre-filled pens
干预措施: Gan & Lee Insulin Glargine Injection (Drug)
Lantus ® EU
Active Comparator
Insulin glargine (Lantus®, product marketed in Germany (EU RP)), 100 U/mL in 3 ml pre-filled pens
干预措施: Gan & Lee Insulin Glargine Injection (Drug)
Gan & Lee Insulin Glargine
Experimental
Insulin glargine 100 U/mL in 3 mL pre-filled pens
干预措施: Gan & Lee Insulin Glargine Injection (Drug)
结局指标
主要结局
PD endpoint
时间窗: Up to 30 hrs
GIR max, maximum observed glucose infusion rate
PK endpoint
时间窗: Up to 30 hrs
Cins.max, maximum observed insulin concentration.
次要结局
- Secondary PK endpoint(Up to 30 hrs)
- Exploratory PK endpoint(Up to 30 hrs)
- Secondary PD endpoint(Up to 30 hrs)
- Safety endpoints(Up to 12 Weeks)
- Exploratory PD endpoint(Up to 30 hrs)
研究者
研究点 (2)
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