Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Incidence of immune response
研究概览
简要总结
This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients
详细描述
Previous study has revealed that Insulin Glargine (Kalbe Farma) has similar efficacy with Lantus (Sanofi-Aventis) in controlling blood glucose in type 2 diabetes mellitus patients, but the immunogenicity potential of this product has not been known. Therefore, the present study is aiming to compare immunogenicity of Insulin Glargine (Kalbe Farma) and Lantus (Sanofi-Aventis) in type 2 diabetes mellitus patients in an open-label randomised multicenter clinical study.
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
- Single (Participant)
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
- •Men or women, 18 years old and above
- •Diabetes mellitus type 2 patients who has failed an oral hypoglycemic drug products, insulin-naive, disease duration of at least 6 months, inadequate glycemic control (HbA1c > 7.0 %)
- •BMI ranged from 19 - 35 kg/m2
- •Consent from patients of childbearing potential to use contraception method throughout the study
- •Signed informed consent form
排除标准
- •History of diabetic ketoacidosis more than 2 times in the past 1 year
- •History of pancreatectomy
- •Estimated glomerular filtration rate <30 mL/min
- •Positive ZnT8 Antibody
- •Treatment with glucocorticoids, immunodepressant or cytostatics in 60 days before study.
- •Any malignant disease, including in medical history
- •Drugs and alcohol abuse, including in medical history
- •Hipersensitivity to insulin glargine or any excipient of the drugs from medical history
- •Mental disorders
研究组 & 干预措施
Insulin Glargine Ezelin
Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)
干预措施: Insulin Glargine Ezelin (Drug)
Insulin Glargine Lantus
Insulin Glargine Pen Injector [Lantus]
干预措施: Insulin Glargine Pen Injector [Lantus] (Drug)
结局指标
主要结局
Incidence of immune response
时间窗: 6 months
Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups
次要结局
- HbA1c(6 months)
- Fasting blood glucose(6 months)
- Hypoglycemia(6 months)
- Adverse events(6 months)
研究者
Dr Tri Juli Edi Tarigan, SpPD-KEMD
Endocrinologist, Principal Investigator
Indonesia University