CTRI/2024/10/074715招募中3 期
A Randomized, Multicentric, Open Label, Active-Controlled, Parallel-Group, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Semaglutide Injection of Dr. Reddy’s Laboratories Pvt. Ltd Compared with Ozempic® (Semaglutide) Injection Novo Nordisk A/S, in Subjects with Type 2 Diabetes Mellitus
Dr. Reddy’s Laboratories Ltd.20 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2025年1月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 20
- 主要终点
- To record Mean change in HbA1c from baseline
研究概览
简要总结
This is a A Randomized, Multicentric, Open Label, Active-Controlled, Parallel Group, Phase III, Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Semaglutide Injection of Dr. Reddy’s Laboratories Pvt. Ltd Compared with Ozempic® (Semaglutide) Injection Novo Nordisk A/S, in Patients with Type 2 Diabetes Mellitus.
The purpose of the present trial is to compare Semaglutide injection of Dr. Reddy’s Laboratories Pvt. Ltd with Ozempic® (Semaglutide) Injection (subcutaneous) of Novo Nordisk A/S, in terms of glycemic control, weight loss, and other efficacy and safety parameters in subjects with T2DM.
The study will be conducted at multiple study centers across India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be enrolled in the study if they meet all the following criteria.
- •1.Adult human subjects aged between 18 to 65 years (both inclusive) with diagnosis of type 2 diabetes mellitus.
- •2.Subjects with glycosylated haemoglobin (HbA1c) levels of 7.0% to 10.5% (both inclusive) Subjects on stable dose of Metformin ≥1500 mg within 12 weeks of Screening Visit Female subjects of child-bearing potential and male subjects who are engaging in sexual activity with female partner of child-bearing potential that could lead to pregnancy,must use at least 1 of the following adequate birth control methods while on study treatment and for 4 weeks after the last exposure to investigational product.
- •Acceptable contraception methods include: Male partner with vasectomy, OR Male condom AND partner use of at least 1 of the contraceptive options below: a) Female Condom with Spermicide or Diaphragm b) Contraceptive subdermal implant that meets effectiveness criteria including a less than 1% rate of failure per year, as stated in the product label.
- •c)Intrauterine device or intrauterine hormonal system that meets effectiveness criteria including a less than 1% rate of failure per year, as stated in the product label d) Combined oral contraceptive.
- •e) Injectable progestogen f)Contraceptive vaginal ring.
- •Willing to provide written informed consent, as applicable, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF); written informed consent will be obtained prior to any study related procedures.
排除标准
- •Subjects will not be entered into the study only if they meet any of the following criteria.
- •Known or suspected hypersensitivity to investigational product(s) or related products.
- •Subjects with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
- •Subjects with a history of metabolic acidosis or diabetic ketoacidosis.
- •Subjects with Fasting Plasma Glucose (FPG) more than 270 mg/dL at screening.
- •Subjects with the Body Mass Index (BMI) more than or equal 45.0 kg/m2 at screening.
- •Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days prior to screening.
- •An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness.
- •Subjects with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
- •Subjects with any abnormality on 12-lead ECG at screening that in the opinion of the Investigator is clinically significant and is judged as potential risk for his/her participation in the study.
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC).
- •Family is defined as a first degree relative.
- •Screening serum calcitonin value that is out of range as per central laboratory’s reference range
- •History or presence of pancreatitis (acute or chronic).
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within 180 days prior to the day of Screening Visit.
- •Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- •Planned coronary, carotid or peripheral artery revascularization known on the day of Screening Visit.
- •Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 as per the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
- •Subjects with alanine aminotransferase (ALT) and AST greater than 2.5 x upper limit of the normal (ULN).
- •Subjects with uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •To determine the subject’s eligibility at Screening and Baseline, a single repeat of tests or procedures may be allowed at the discretion of the Investigator, the Medical Monitor should be consulted if needed.
结局指标
主要结局
To record Mean change in HbA1c from baseline
时间窗: Week 24
次要结局
- 1.To record mean change in HbA1c from baseline.(2.Mean change in weight from baseline .)
研究者
Dr Jayashri Krishnan
JSS Medical Research Asia pacific Private Limit
研究点 (20)
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