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
- 52
- 主要终点
- Change from Baseline in HbA1c
研究概览
简要总结
This is a phase 3, randomized, open-label, multicenter, parallel-group, active-controlled study. The study will be conducted at approximately 15-20 centers from various parts of India, having qualified Investigators. The study will be initiated only after the receipt of Regulatory and EC approval.
The study will randomize approximately 314 patients. The screening period will be of 2 weeks. During screening period, after obtaining the written informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessments (Appendix I). After confirming eligibility, patients will be randomized in 1:1 ratio (157 patients in Test arm and 157 in Comparator arm) into either Test arm or Comparator arm. Patients will receive either Semaglutide Injection or Reference Biologic Injection, subcutaneously, based on treatment arm as per the dosing schedule.
All patients will be provided with diary at the time of enrolment along with glucometer to record details about study drug administration, adverse events (AEs), rescue medications (if any) and self-monitoring of blood glucose levels. Patients will be required to bring completed diary and glucometer at each visit. Patient will be provided with ‘instruction for use’ document and will be trained on how to administer the study product.
During the study, assessments will be performed as mentioned in Schedule of Assessments (Appendix I). Patients terminating early from the study will be completing EOT assessments. EOS visit will be conducted after 2 weeks post EOT assessments. The efficacy and safety will be assessed during the study period.
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 gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
- •Patients with diagnosis of T2DM with HbA1c ≥7.0% and ≤10.5% 3) Patients along with diet and exercise control, additionally on stable daily dose of metformin (≥1500 mg or maximum tolerated dose based on clinical record) within 12 weeks prior to the day of screening 4) 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 the 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].
排除标准
- •Patients with history of hypersensitivity to any of the study drug or its excipients or to drugs of similar chemical classes 2) Patients with Fasting Blood Glucose (FBG) greater than or equal to 270 mg/dL at screening 3) Treatment with any medication for diabetes or obesity 90 days or less before screening 4) History of pancreatitis (acute or chronic) 5) 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 6) Patients presently classified as being in New York Heart Association (NYHA) Class III or IV 7) Patients with planned coronary, carotid or peripheral artery revascularisation known on the day of screening 8) 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) before screening 10) Patients diagnosed with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) 11) 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) 12) 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 13) Pre-planned surgery or medical procedure that would interfere with the conduct of the study 14) Patients with known alcohol or other substance abuse within last one year of screening 15) Employee of the Sponsor, 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 or the Investigator 16) Pregnant, lactating women or women who intends 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: Timeframe: Baseline, Week 24
次要结局
- Change from Baseline in HbA1c levels(Timeframe: Baseline, Weeks 4, 8, 12, 16, and 20)
- Change from Baseline in FBG levels(Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Change from Baseline in PPBG levels(Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24)
- Change from Baseline in Bodyweight and BMI(Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Change from Baseline in Systolic and Diastolic Blood Pressure(Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Change from Baseline in Fasting Lipid Profile Parameters(Timeframe: Baseline, Weeks 8 and 24)
- Proportion of patients achieving HbA1c less than 7.0%(Timeframe: Baseline, Weeks 8, 12, 16, 20 and 24)
- Proportion of patients receiving rescue medications(Timeframe: Throughout the study period)
- Incidence of TEAEs and SAEs(Throughout the study period)
- Proportion of patients requiring hypoglycaemia management(Timeframe: Throughout the study period)
- Proportion of patients with ADA and NAb(Timeframe: Baseline (Pre-dose), Week 24])
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited