CTRI/2025/03/082615已完成3 期
A Multicenter, Randomized, Comparative, Active-Controlled, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic in Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 24
- 主要终点
- Change in HbA1c from baseline at the end of Week 24.
研究概览
简要总结
This is a Multicenter, Randomized, Comparative, Active-Controlled, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Semaglutide Injection in Comparison with Reference Biologic in Type 2 Diabetes Mellitus.
The patients with T2DM with diet and exercise control, additionally on stable daily dose of metformin (more than or equal to 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to screening will be screened (visit 1) within 2 weeks prior to their enrolment. The eligible patients will then be enrolled and randomized to either of the 2 study groups as per their randomization number on baseline visit (visit 2, week 0, day 0). After randomization, patients will then be followed up on an outpatient basis with scheduled visits at week 4 (visit 3), week 8 (visit 4), week 12 (visit 5), week 16 (visit 6), week 20 (visit 7) and week 24 (visit 8 - End of Treatment [EOT]). After 2 weeks of treatment, there will be a safety follow-up through telephonic visit at week 26 (visit 9 - End of Study [EOS]). This will be a parallel group study and all the enrolled patients will be instructed to take the study medications for a treatment period of 24 weeks.
Both the Test product and Comparator product will be administered once weekly at any time of day, with or without meals for 24 weeks. If a dose is missed, the missed dose will be administered within 5 days of the missed dose. Injection will be administered subcutaneously in the abdomen, thigh, or upper arm. Apart from study medications, throughout the treatment period, all subjects will receive stable daily dose of metformin (more than or equal to 1500 mg or maximum tolerated dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients of either sex, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
- •Patients with diagnosis of type 2 diabetes with glycosylated haemoglobin (HbA1c) more than or equal to 7.0 % and less than or equal to 10.5%.
- •Patients along with diet and exercise control additionally on stable daily dose of Metformin (more than or equal 1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to the day of screening.
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till last dose of the study medication (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence).
- •[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
- •Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age].
- •Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with the protocol requirements.
排除标准
- •Patients with history of hypersensitivity to any of the study drug or to drugs of similar chemical classes.
- •Patients with fasting plasma glucose (FPG) more than or equal to 270 mg/dL at screening.
- •Treatment with any medication for diabetes or obesity 90 days or less before screening [other than Metformin, or short-term insulin (less than or equal to 14 days in total)].
- •Serum Calcitonin level more than or equal to 50 ng/L at screening
- •History of pancreatitis (acute or chronic).
- •Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack within the past 180 days prior to the day of screening.
- •Subjects presently classified as being in New York Heart Association (NYHA) Class and III or IV.
- •Patients with planned coronary, carotid or peripheral artery revascularization known on the day of screening.
- •Patients having significant renal (estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m2, as calculated on MDRD formula) or hepatic impairment (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase (ALP) greater than 3 x upper limit of normal [ULN]), total bilirubin greater than 1.5 x ULN; hemoglobin less than 9 g/dL, WBC count less than 2500/mm3 (less than 2.5 × 103/μL), neutrophil count less than 1500/mm3 (less than 1.5 × 103/μL), platelet count less than 100 ×103/mm3 (less than 100 × 103/μL).
- •History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas).
- •Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g., Orlistat, thyroid hormones, corticosteroids).
- •Patients with history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
- •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 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 of screening.
- •Employee of the Sponsor/CRO, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor/CRO or the Investigator.
- •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 in HbA1c from baseline at the end of Week 24.
时间窗: Baseline and Week 24.
次要结局
- Change in HbA1c from baseline at the end of Week 4, 8, 12, 16 and 20.(Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20.)
- Change in Postprandial Glucose (PPG) from baseline at the end of Weeks 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Change in FPG from baseline at the end of Weeks 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Proportion of Participants Achieving HbA1c less than 7.0% at Weeks 8, 12, 16, 20 and 24.(Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Change in body weight and BMI from baseline at the end of Week 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Number of patients receiving rescue medications.(Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Change from baseline in fasting blood lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides) at Week 24.(Baseline and Week 24.)
- Change in systolic and diastolic blood pressure from Baseline at the end of Week 4, 8, 12, 16, 20 and 24.(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.)
- Adverse events and Serious adverse events (SAE) reported during the study.
- Number of patients requiring hypoglycaemia management.(Throughout the study.)
- Number of patients discontinued due to AEs during course of trial.(Throughout the study.)
- Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (Nab) at week 24 compared to pre-dose (enrolment, Day 0 – visit 2).(Day 0 and Week 24.)
研究者
Dr Deven V Parmar
Zydus Lifesciences Limited
研究点 (24)
Loading locations...
相似试验
已完成
3 期
A clinical study to evaluate the efficacy and safety of Semaglutide Injection in patients with weight management.CTRI/2025/03/082620Zydus Lifesciences Limited282
招募中
3 期
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational AgeSmall for Gestational AgeNCT07309562Xiamen Amoytop Biotech Co., Ltd.141
已完成
3 期
A Study to assess effectiveness and safety of Semaglutide Injection compared to Ozempic (semaglutide injection) in Type 2 Diabetes MellitusCTRI/2025/02/080592Sun Pharmaceutical Industries Limited314
尚未招募
3 期
A Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based TreatmentNCT07392060Shanghai Jiatan Pharmatech Co., Ltd440
招募中
4 期
A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye DiseaseThyroid Eye DiseaseNCT07265258Innovent Biologics (Suzhou) Co. Ltd.92