CTRI/2025/10/095698尚未招募3 期
A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Oral Semaglutide Tablets of Sun Pharma Laboratories Limited in Comparison to Rybelsus (Semaglutide) Tablets in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 314
- 试验地点
- 25
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
This will be a prospective, multicenter, randomized, double-blind, double-dummy, active-controlled, Phase 3 Study. The study will be conducted at approximately 20-30 centres from various parts of India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee approval. The study will randomize approximately 314 patients.
During screening period, after obtaining the written informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessments.
After confirming eligibility, patients will be randomized in 1:1 ratio to either Test arm or Comparator arm
The efficacy and safety will be assessed during the study period as mentioned in Schedule of Assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex, aged 18 to 65 years (both inclusive) and who are willing to give written informed consent to participate in the study.
- •Patients with diagnosis of T2DM with glycated haemoglobin (HbA1c) more than equal to7.0% and less than equal to 10.5%.
- •Patients along with diet and exercise control, on stable daily dose of metformin (more than equal to 1500 mg or maximum tolerated dose based on clinical record) for at least 12 weeks prior to the day of screening.
- •Women of childbearing potential must have a negative urine pregnancy test at study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (
- •Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period.
排除标准
- •Patients with history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or any of the excipients of the study drugs.
- •Patients with Fasting Blood Glucose (FBG) more than equal to 270 mg/dL at screening.
- •Treatment with any medication for diabetes or obesity within 90 days before screening (other than metformin, or short-term insulin [less than equal to14 days in total].
- •Patients with myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack within the past 180 days; history of or planned coronary, carotid or peripheral artery revascularization known on the day of screening.
- •Patients presently classified as being in New York Heart Association (NYHA) Class and III or IV heart failure.
- •Patients having significant renal or hepatic impairment (
- •History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas).
- •Patients with proliferative/ unstable retinopathy and maculopathy
- •Patients with history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- •Patients diagnosed with type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g., Cushing syndrome or acromegaly- associated diabetes).
- •Any condition (e.g., infection, trauma and surgery) which require insulin therapy (other than short term insulin therapy) at the time of screening or during the study period.
- •Patients with any clinically significant laboratory abnormalities/condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
- •Pre-planned surgery or medical procedure that would interfere with the conduct of the study
- •Patients with known alcohol or other substance abuse within last one year.
- •Pregnant, lactating women or women who intend to conceive or women of childbearing age who are not willing to use an acceptable method of birth control during the study period.
结局指标
主要结局
Change from baseline in HbA1c
时间窗: Baseline, Week 24
次要结局
- Change from baseline in HbA1c(Baseline, Weeks 12, 16 and 20)
- Change from baseline in FBG(Baseline, Weeks 4, 8, 12, 16, 20 and 24)
- Change from baseline in Postprandial Blood Glucose (PPBG)(Baseline, Weeks 4, 8, 12, 16, 20 and 24)
- Change from baseline in body weight and BMI(Baseline, Week 24)
- Change from baseline in fasting lipid profile parameters [total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL)cholesterol, very low-density lipoprotein (VLDL) cholesterol, Triglyceride (TG)](Baseline, Week 24)
- Proportion of patients achieving HbA1c less than 7.0%(Weeks 12, 16, 20 and 24)
- Proportion of patients receiving rescue medications(Throughout the study period)
- Incidence of TEAEs and SAEs(Throughout the study period)
- Proportion of patients requiring hypoglycaemia management(Throughout the study period)
- Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (NAb)(Baseline [Day 0, Pre-dose], Week 24)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (25)
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