CTRI/2025/10/096183尚未招募3 期
A Phase 3 multicenter randomized double blind double dummy parallel group study to compare the efficacy and safety of Alkem Tab Semaglutide versus innovator Semaglutide (Tab Rybelsus Novo Nordisk) in patients with Type 2 Diabetes Mellitus inadequately controlled on metformin
Alkem Laboratories Limited23 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2025年10月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 23
- 主要终点
- Change in HbA1c levels from baseline to Week 24
研究概览
简要总结
| A Phase 3 multicenter randomized double blind double dummy parallel group study to compare the efficacy and safety of Alkem Tab Semaglutide versus innovator Semaglutide (Tab Rybelsus Novo Nordisk) in patients with Type 2 Diabetes Mellitus inadequately controlled on metformin |
A total 232 patients who meet the eligibility criteria will be randomized in the ratio of 1:1 to receive either test product or reference product for 24 weeks.
The total study duration will be approximately 13 months considering screening period of 2 weeks, about 6 months of recruitment period and 24 weeks of study period.
Screening Period: Up to 2 weeks
Treatment Period: It will last for 24 weeks
End of study (EOS) assessment: EOS assessment will be performed at Week 24
The primary and secondary endpoint of this trial are as follow:
Primary efficacy endpoint:
Change in HbA1c levels from baseline to Week 24
Secondary efficacy endpoint(s):
Change in body weight from baseline to Week 24
Change in fasting plasma glucose (FPG) from baseline to Week 24
Change in post-prandial blood glucose (PPG) levels from baseline to Week 24
Percentage of patients requiring dose escalation to 14 mg/day post week 16
Safety endpoints:
Treatment emergent serious and non-serious adverse events (AEs) during the study
Alteration in clinical laboratory parameters during the study (hematology, biochemistry including Sr. Calcitonin)
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
- •The patients will be included in the study based on the following criteria:
- •Willing to provide voluntary written informed consent and able to comply with the protocol requirements
- •Male or female patients with Type 2 DM of 18 to 65 years of age (both inclusive)
- •Patients who have inadequate glycemic control with at least 1000 mg/ day of metformin for 8 weeks
- •Patients with HbA1c value between 7%.
排除标准
- •The patients will be excluded from the study based on the following criteria:
- •Known hypersensitivity to Semaglutide or to any of the excipients of the investigational products
- •Patients with BMI more than equal to 40 kg/m2
- •Laboratory findings measured at screening: a.
- •Hemoglobin less than 10 g/dl b.
- •Neutrophils less than 2000/mm3 c.
- •Total bilirubin more than 1.5 X ULN e.
- •ALT/ AST more than 2.5 X ULN f.
- •Any other screening laboratory value that is clinically significant in the Investigator’s opinion precluding patient’s participation in the study
- •Patients with Type 1 DM
- •Acute decompensation of glycemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
- •Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
- •History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- •Sr. Calcitonin at screening above or equal to 50 ng/L
- •Patients with history of diabetic retinopathy
- •Currently planned coronary, carotid or peripheral artery revascularization
- •Chronic heart failure New York Heart Association (NYHA) class III & IV
- •Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
- •Personal history of non-familial medullary thyroid carcinoma
- •Presence or history of malignant neoplasm within 5 years prior to the day of screening
- •Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
- •Patients with hypothyroidism or hyperthyroidism including patient on controlled thyroid function test on medications
- •Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis etc.)
- •Patients with acute conditions with the potential to alter renal function such as dehydration, severe infection, shock, or intravascular administration of iodinated contrast agents
- •Any condition (e.g. infection, trauma, and surgery) which require insulin therapy at the time of screening or during the study period.
- •Patients with history of myocardial infarction, coronary artery bypass surgery or percutaneous coronary intervention, stroke or transient ischemic attack within past 3 months
- •Patients with history of pancreatitis
- •Positive testing for HIV, hepatitis B (hepatitis B virus surface antigen [HBsAg]) or hepatitis C (hepatitis C virus antibody [HCV Ab]) virology
- •Women of childbearing potential not ready to use an effective barrier contraceptive method during the study.
- •(Patient using oral contraceptives or likely to use oral contraceptive during the study will not be eligible to participate in the study)
- •Pregnant or lactating women
- •Patients with clinically significant medical history, vital signs, physical examination requiring exclusion of the patient as deemed by the investigator or designee.
结局指标
主要结局
Change in HbA1c levels from baseline to Week 24
时间窗: Baseline to Week 24
次要结局
- Change in body weight from baseline to Week 24(Change in fasting plasma glucose (FPG) from baseline to Week 24)
研究者
Dr Akhilesh Sharma
Alkem Laboratories Limited
研究点 (23)
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