CTRI/2021/11/037994招募中3 期
A Prospective, Multi-center, Randomized, Open-Label, Parallel-group, Active-controlled, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Insulin Glargine 100 IU/mL Injection of M.J. Biopharm Private Limited with Lantus® (Insulin Glargine Injection) 100 units/mL in the Treatment of Patients Diagnosed withType 2 Diabetes Mellitus.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 15
- 主要终点
- Mean change in HbA1c from baseline to Week 24 compared with Lantus®
研究概览
简要总结
A Prospective, Multi-center, Randomized, Open-Label, Parallel-group, Active-controlled Phase III study to Compare the Efficacy, Safety and Immunogenicity of Insulin Glargine 100 IU/mL injection of M.J. Biopharm Private Limited with Lantus® (Insulin Glargine Injection) 100 units/mL in the treatment of Patients diagnosed with Type 2 Diabetes Mellitus
Primary Objective:
To determine the non-inferiority of Insulin Glargine of MJBPL to Lantus® (Insulin Glargine Injection), as measured by change in glycated haemoglobin A1c (HbA1c) over the treatment period
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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 provide the written informed consent
- •Male and female adult patients, at an age of 18 to 65 years, both inclusive
- •Type 2 diabetes mellitus based on the disease diagnostic criteria provided by World Health Organization (WHO) guidelines
- •Duration of diabetes mellitus greater than or equal to 12 months
- •Receiving 2 or more Oral Antidiabetic Medicinal products (OAMs) at stable doses for 12 weeks prior to screening, with or without Lantus®.
- •The use and dose of oral agents in combination with insulin had to be in accordance with the product label.
- •If on Lantus, must be on once daily stable dose (±15% variation in dose) for at least 3 months prior to screening.
- •Haemoglobin level of ≥9.0 g/dL
- •Body mass index (BMI) between 18 and 38 kilograms/meter square (kg/m²)
- •Stable weight, with no significant and appreciable loss or gain, in the 3 months prior to screening; this information will be obtained by patient interview during medical history
- •Female patients of childbearing potential, in addition to having a negative serum pregnancy test, must be willing to use a reliable means of contraception (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.), surgical sterilization (at least 6 months prior to study drug administration) or abstinence for the duration of the study.
- •Patients should use the reliable method of contraception from screening, during study and up to and for at least two weeks after treatment discontinuation
- •Ability and willingness to administer study medication daily as injections to abdomen, thigh, or upper arm
- •As determined by the investigator, the patient should be capable and willing to do the following: a.
- •Perform self-monitored blood glucose (SMBG) b.
- •Complete Subject diaries as instructed c.
- •Be receptive to diabetes education d.
- •Be able and willing to adhere to the protocol requirements.
排除标准
- •Type 1 diabetes mellitus
- •Used any other insulin except Lantus® within the previous 30 days.
- •Have been on Lantus® more than once daily within the previous 30 days.
- •Exposed to a biosimilar insulin glargine within the previous 90 days
- •History of taking basal bolus therapy or, in the investigator’s opinion, required mealtime insulin to achieve target control
- •Type 2 Diabetes patients with metabolic complications such as diabetic ketoacidosis within 6 months of screening visit
- •Used thiazolidinediones (TZDs) within the previous 90 days
- •Excessive insulin resistance at study entry (total insulin dose ≥1.5 U/kg)
- •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
- •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)
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60 mL/min/1.73 m2 at screening.
- •Evidence of hypokalemia (serum potassium < 3.5 mmol/L at screening)
- •Known case of chronic liver disease or hepatic impairment, defined as any serum liver enzymes (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase) ≥ 2.5 times ULN 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
- •History of or ongoing cardiac dysrhythmias requiring treatment, such as uncontrolled atrial fibrillation
- •Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol
- •Active cancer or personal history of cancer within previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
- •Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness, or positive HIV seropositivity at screening
- •Known active or chronic hepatitis B or hepatitis C infection, or Hepatitis B and Hepatitis C seropositivity at screening, if not related to vaccination
- •Blood transfusion or severe blood loss within 3 months prior to screening, or known haemoglobinopathy, hemolytic anemia, or sickle cell anemia
- •Prohibited medications which cannot be discontinued at randomization or anticipated initiation or change in concomitant medications known to affect glucose metabolism
- •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.
- •Have any other condition (including history of/known drug or alcohol abuse or psychiatric disorder including dementia) that precludes the participant from following and completing the protocol as per judgment of the investigator.
结局指标
主要结局
Mean change in HbA1c from baseline to Week 24 compared with Lantus®
时间窗: From baseline to end of treatment period (Week 24)
次要结局
- Mean change in HbA1c from baseline to Week 12 compared with Lantus®(From baseline to Week 12)
- Change in FPG and PPPG from baseline to Week 12 and Week 24(From baseline to Week 12 and Week 24)
- Proportion of patients with HbA1c reduction of ≥1% from baseline to Week 12 and Week 24(From baseline to Week 12 and Week 24)
研究者
研究点 (15)
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