CTRI/2023/03/050804已完成3 期
A Randomized, Assessor Blind, Active-Controlled, Multicenter, Parallel Group, Non-Inferiority Study to compare the Efficacy and Safety of GEN1501 (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) of GeneSys Biologics Pvt. Ltd., India with LANTUS® (Insulin Glargine (r-DNA Origin) Injection 100 Units/mL) in patients with Type 2 Diabetes Mellitus on Uncontrolled Oral Antidiabetic therapy (OAD)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 20
- 主要终点
- The change of Glycosylated Hemoglobin (HbA1C) from baseline to the time period
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of GeneSys Insulin Glargine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to give informed consent.
- •Age: between 18-65 years, both inclusive.
- •Insulin- naïve male or female subjects with type 2 diabetes mellitus, as per WHO Criteria 2006 [fasting plasma glucose ≥ 7.0mmol/l (126mg/dl) or 2–h plasma glucose ≥ 11.1mmol/l (200mg/dl)].
- •Established diagnosis of type 2 diabetes for more than one year.
- •On oral antidiabetic therapy [≥ two drugs- AGI (α-Glucosidase inhibitors), DPP-4 (Dipeptidyl peptidase-4) inhibitors, MEG (Meglitinides), MET (metformin), SU (Sulfonylureas), GLP1-RA (Glucagon-like peptide-1 receptor agonists)] stable doses, for at least 12 weeks prior to study entry.
- •Stable weight, with no more than 5 kg gain or loss, in the 3 months prior to screening.
- •Body Mass Index 18 to 35 Kg/m
- •Glycosylated hemoglobin.
- •HbA1C ≥ 7.0 and ≤ 10.0% and stratification criteria ≤ 8.5% and > 8.5%.
- •Women of child-bearing potential willing to use an effective method of contraception.
- •Ability and willingness to perform self-monitored blood glucose (SMBG).
- •Monitoring using a blood glucose meter and to use a subject diary.
- •Ability to self-administer Insulin glargine by subcutaneous injection, upon training by site personnel.
- •Haemoglobin level of ≥9.0 g/dL.
- •Be able and willing to adhere to the protocol requirements.
- •Be receptive to diabetes education.
排除标准
- •Type 1 diabetes mellitus
- •Type 2 diabetic subjects on Thiazolidinedione (TZD) therapy
- •Used glucagon-like peptide 1 (GLP-1) agonist, thiazolidinediones (TZDs) within the previous 90 days.
- •More than one episode of severe hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, within 6 months prior to study entry
- •An episode of moderate to severe Diabetic ketoacidosis in the last three months prior to screening needing inpatient or outpatient care.
- •Clinically significant abnormal hepatic (e.g., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 1.5x ULN) or renal function lab tests (e.g., creatinine greater than 1.25x ULN) suggestive of hepatic or renal impairment.
- •History of renal transplant.
- •Severe peripheral vascular disease which has resulted in amputation, chronic foot ulcer, claudication or absent pulses.
- •Known history of autonomic neuropathy.
- •Pregnancy or women intending to become pregnant during the trial period and Breast feeding.
- •Blood donation within the last 30 days.
- •Subjects with history of alcohol or drug abuse or smokers.
- •Treatment by another Investigational Medicinal Product during the 6 months prior to screening.
- •History of hypersensitivity to the trial drugs or to drugs with a similar chemical structure or excipients.
- •History of severe or multiple allergies.
- •Any condition which requires administration of systemic corticosteroid in the last 2 weeks prior to screening or any condition which requires chronic treatment with systemic corticosteroids.
- •Current significant cardiovascular, respiratory, gastrointestinal diseases.
- •Major surgical procedure within 6 months of screening.
- •Subjects with history of HIV, Hepatitis B and/or Hepatitis C.
- •Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol.
- •Exposed to a biosimilar insulin glargine within the previous 90 days.
- •Excessive insulin resistance at study entry (total insulin dose ≥1.5 U/kg).
- •Known hypersensitivity or allergy to insulin glargine or its excipients OR history of significant allergic drug reactions.
- •Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy at pharmacological doses (excluding topical, intra-articular, intra-ocular, or inhalational preparations and physiologic replacement doses for adrenal deficiency) or had received such therapy within 4 weeks prior to screening.
- •Inadequately treated hypertension (systolic ≥150 mm Hg or diastolic ≥100 mm Hg).
- •Evidence of hypokalemia (serum potassium < 3.5 mmol/L at screening).
- •Congestive heart failure (New York Heart Association [NYHA] class III & class IV), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism or any other established major cardiovascular disease prior to screening.
- •Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol.
- •Breastfeeding, pregnant, or intended to become pregnant during the course of the study, or were sexually active women of childbearing potential not actively practicing birth control using a method deemed to be medically acceptable by the investigator.
- •Undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study.
- •Clinically significant laboratory values at screening which in the judgement of Investigator can interfere with study assessments or pose safety risk to the subject.
- •If participated in any other clinical trial within the last 6 months before the current study or concurrently enrolled/scheduled to be enrolled in any other type of medical research during the current study period.
结局指标
主要结局
The change of Glycosylated Hemoglobin (HbA1C) from baseline to the time period
时间窗: 12 weeks
次要结局
- The proportion of subjects reaching glycemic target (HbA1C 7%) shall be evaluated.(Week 12 & 24)
- Change in Fasting Blood Glucose from baseline(-)
- Change in Postprandial Blood Glucose from baseline.(-)
- The change in body weight of the subjects in either arms shall be calculated.(at the end of 24 weeks)
- The change of Glycosylated Hemoglobin (HbA1C) from baseline to the time period.(24 weeks)
- Mean change from baseline of self-monitored blood glucose (SMBG) levels(week 12 & 24 in both the arms)
研究者
研究点 (20)
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