A multicenter, randomized, comparative, active controlled, open label, Phase III Study to evaluate the efficacy and safety of Semaglutide Injection in comparison with Ozempic (Semaglutide) Injection in Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 20
- 主要终点
- Change from Baseline in HbA1c
研究概览
简要总结
Type 2 Diabetes Mellitus (T2DM) is characterized by progressively diminished response to insulin also known as “Insulin Resistance” that results in sequential adding of different oral and injectable medications to achieve optimal glycemic control. First-line treatment strategies for T2DM are lifestyle modification and use of Biguanides (Metformin, Proguanil) and Insulin Secretagogues like Sulphonylureas (Tolbutamide, Glimepiride) and Megaltidines class of drugs (Nateglinide and Repaglinides). However, almost 50% of patients with T2DM will require additional antihyperglycemic medication(s) within one year of diagnosis. Diabetes associations globally stress importance of a patient-centered approach especially when choosing add-on therapy.
GLP-1 receptor agonists stimulate insulin secretion and suppress glucagon release in a glucose-dependent manner, thereby effectively controlling blood glucose in patients with T2DM without excess risk of hypoglycaemia. The results from dedicated cardiovascular outcome trials have shown their cardiovascular safety, and for some of them have also proven additional cardiovascular benefits (liraglutide, subcutaneous semaglutide, albiglutide and dulaglutide). As per the ADA guidelines, GLP-1 receptor agonists have a high to very high efficacy in T2DM with no hypoglycaemia risk. Semaglutide also has beneficial cardiovascular effects with neutral effects on heart failure.
Natco Pharma Limited has developed a proposed biosimilar to semaglutide Injection, (Ozempic®) and intends to conduct a phase III clinical study in India. It is comparable to the RMP in terms of its physicochemical characteristics, structure, and mechanism of action. Taking into account the results of the analytical similarity, pharmacological, and toxicological profiles of IMP, and previous clinical and marketing experience of Ozempic®, the present study has been planned to compare the efficacy and safety of IMP versus Ozempic® in T2DM.
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 glycated haemoglobin (HbA1c) more than or equal to 7.0 percent and less than or equal to 10.5 percent
- •Patients with Body Mass Index BMI more than or equal to 18 kg per meter square.
- •Patients along with diet and exercise control, additionally on stable daily dose of metformin (more than or equal to 1500mg 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 the last dose of the study medication.
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.
- •Patients with Fasting Blood Glucose (FBG) more than or equal to 270mg per dL at screening.
- •Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
- •Serum Calcitonin level more than or equal to 50 ng per 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.
- •Patients presently classified as being in New York Heart Association (NYHA) Class 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 30mL per min per 1.73 msq, as calculated on MDRD formula) or hepatic impairment (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and alkaline phosphatase (ALP) more than 3×upper limit of normal [ULN]), total bilirubin more than 1.5×ULN, hemoglobin less than 9 g per dL, WBC count less than 2500 per mmcube, neutrophil count less than 1500 per mm per cube, platelet count less than 100×1000 per mmcube.
- •History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) before screening.
- •Proliferative diabetic retinopathy or maculopathy requiring acute treatment.
- •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 diagnosed with 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 or 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, 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.
- •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: Week 25
次要结局
- Change from Baseline in HbA1c levels(Weeks 5, 9, 13, 17, and 21)
- Change from Baseline in FBG levels(Weeks 5, 9, 13, 17, 21, and 25)
- Change from Baseline in postprandial blood glucose (PPBG) levels(Weeks 5, 9, 13, 17, 21, and 25)
- Change from Baseline in BMI(Weeks 5, 9, 13, 17, 21, and 25)
- Proportion of patients achieving HbA1c less than 7.0 percent(Weeks 9, 13, 17, 21 and 25)
- Proportion of patients receiving rescue medications(Throughout the study period)
研究者
Mr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.