The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin® Log-G With Its Reference Lantus® in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients
详细描述
Sansulin® Log-G is an insulin glargine biosimilar. For a biosimilar, its efficacy, safety, and immunogenicity should be compared head-to-head with its reference product in at least non-inferiority study. Immunogenicity assessment should always be done because it is influenced by so many factors, from nature of the drug substance until patient and disease related factors. Moreover its consequences also vary considerably, from clinically irrelevant to serious and life-threatening. Immunogenicity of a biosimilar should always be investigated in humans, since animal data are usually not predictive of the immune response in humans.
Since blinding of study participants is likely unfeasible, at least anti-drug antibodies should be determined in a blinded fashion. Since anti-insulin antibodies develop early, then 6 months duration of study is adequate.
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
- •Patients with DM type 2, age at least 18 years, both genders.
- •T2DM patients who have been diagnosed for > 1 year, and have been treated with one oral antidiabetic at stable doses for > 3 months prior to screening, have BMI of 18.0 to 35.0 kg/m2 inclusive, and HbA1C of > 7.0% and insulin-naive.
- •Patients who are cooperative, reliable, and agree to have regular injections of insulin, and are willing to comply with protocol procedure (willing to sign the informed consent).
- •Female patients with adequate protection from conception. Females of childbearing potential must use a reliable method of birth control during the study (barrier-method or IUD). Women with history of bilateral tubal ligation, or with total hysterectomy, or who are 2 years postmenopausal are also eligible.
排除标准
- •Pregnancy (confirmed by a positive urine pregnancy test) or lactation.
- •History of severe hypoglycemia during the last year (blood glucose level <50 mg/dl with transient dysfunction of central nervous system without other apparent cause)
- •History of diabetic ketoacidosis > 2x within the last year.
- •Having hyperglycemia hyperosmolar status (HHS)
- •Renal impairment (eGFR < 30 mL/min).
- •An employee of the Investigator or the Sponsor.
- •Participating in another clinical study within the past 3 months.
- •Receiving any immunosuppressants, including corticosteroids or cytostatics within the last year or during the study.
- •Receiving any drug or supplement with hypoglycemic activity (except oral antidiabetics) within 4 weeks prior to screening and during the study.
- •Receiving any drug with hyperglycemic activity within 4 weeks prior to screening and during the study (eg. second generation antipsychotics, corticosteroids, tacrolimus, protease inhibitors).
- •Have undergone pancreatectomy or pancreas / islet cell transplant.
- •Mental disorder
- •Any malignancies
研究组 & 干预措施
Insulin Glargine Sansulin
Drug product Insulin Glargine, Sansulin Log-G 100 IU/mL (PT. Sanbe Farma)
干预措施: Insulin Glargine Sansulin (Drug)
Insulin Glargine Lantus
Drug product Insulin Glargine, Pen Injector [Lantus] 100 IU/mL (PT. Sanofi-Aventis)
干预措施: Insulin Glargine Pen Injector [Lantus] (Drug)
结局指标
主要结局
HbA1c
时间窗: 24 weeks
Change in HbA1c level after 24 weeks of therapy compared to baseline value
Number of patients
时间窗: 24 weeks
Number of patients with HbA1c \< 7%
Anti-insulin antibodies (AIAs)
时间窗: 24 weeks
Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value
次要结局
- FBG & PPBG(24 weeks)
- Hypoglycemia(24 weeks)
- Weight gain(24 weeks)
- Adverse events(24 weeks)
研究者
Dr Tri Juli Edi Tarigan, SpPD-KEMD
Endocrinologist, Principal Investigator
Indonesia University