A Prospective, Multi-Centric, Randomized, Open label, Active-Controlled, Parallel Group, Comparative Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Hetero-Semaglutide injection and RMP-Semaglutide injection (Ozempic, Novo Nordisk) in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 37
- 主要终点
- Mean change in glycosylated haemoglobin (HbA1c)
研究概览
简要总结
This is a randomized, multi-centre, open-label, parallel arm, active controlled, comparative clinical study, to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Hetero-Semaglutide injection and RMP-Semaglutide injection (Ozempic, Novo Nordisk) in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin. Patients who are on Metformin greater than or equal to 1500mg/day for about 12 weeks before screening and glycosylated haemoglobin (HbA1c) greater than or equal to 7.0 percentage and less than or equal to 11.0 percentage at screening will be enrolled in this study. The study will consist of up to 14-days screening period, 24 weeks treatment period. Approximately 312 patients will be randomized into either Test arm or Comparator arm. Patients will receive either Hetero Semaglutide Injection or Reference Injection of 0.25 mg, 0.5 mg, 1mg and 2 mg dose will be administer Subcutaneously in the abdomen, thigh, or upper arm once weekly, on the same day each week, at any time of day, with or without meals with initial Starting dose of 0.25 mg once weekly for 4 weeks and followed by Dose Titration. 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), hypoglycaemic episodes, 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. Patients will continue to receive metformin as per pre study dose for entire study duration of 24 weeks.
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
- •Adult male or female patients aged 18-65 years with diagnosis of type 2 diabetes mellitus.
- •Patients who are on Metformin greater than or equal to 1500mg per day for about 12 weeks before screening.
- •Patients with glycosylated haemoglobin (HbA1c) greater than or equal to 7.0 percentage and less than or equal to 11.0 percentage at screening.
排除标准
- •Patients with known Type I diabetes mellitus or secondary diabetes mellitus
- •Patients with history of two or more episodes of severe hypoglycemia within 6 months prior to screening
- •Patients having a history of metabolic acidosis or diabetic ketoacidosis or hyperosmolar state, with or without coma.
- •Patients with severe renal impairment as an estimated glomerular filtration rate less than 30 mL/min/1.73 meter square as calculated by chronic kidney disease-epidemiology collaboration as determined by central laboratory.
- •Patients with hyperthyroidism or hypothyroidism at screening (except those with stable drug dose control for more than 3 months and normal thyroid function tests) or clinically significant abnormal thyroid function test results at screening and requiring drug treatment.
- •Have been taking any other glucose lowering agent(s) other than metformin during the last 12 weeks prior to screening (short-term treatment (no longer than 14 days in total) with insulin in connection with inter-current illness allowed).
- •Patient with any of the following laboratory abnormality at screening a.
- •Haemoglobin less than 10 gm/dl b.
- •Fasting plasma glucose greater than or equal to 270 mg/dL e.
- •Total bilirubin greater than 1.5 X ULN f.
- •ALT/ AST greater than 3 X ULN g.
- •Serum amylase and/or lipase greater than 3.0 X ULN h.
- •Serum calcitonin greater than 50 ng/L i.
- •QTc interval greater than 450 msec in men and greater than 470 msec in women.
结局指标
主要结局
Mean change in glycosylated haemoglobin (HbA1c)
时间窗: Baseline to end of 24 Weeks
次要结局
- Mean change in HbA1c(Baseline to end of 12 Weeks)
- The proportion of patients who achieved HbA1C less than 7.0 percentage(At the End of 12 and 24 Weeks)
- Mean change in fasting plasma glucose (FPG) levels(Baseline to end of 4, 8, 12, 16, 20 and 24 Weeks)
- Mean change in postprandial plasma glucose (PPG) levels(Baseline to end of 4, 8, 12, 16, 20 and 24 Weeks)
- Mean change in body weight(Baseline to end of 12 and 24)
- Proportion of patients who achieved body weight loss greater than or equal to 5 percentage and greater than or equal to 10 percentage(At the End of 12 and 24 Weeks.)
- Proportion of patients who develop anti-drug antibodies (ADA) to Semaglutide(Baseline to end of 12 and 24)
- Proportion of patients with hypoglycaemic episodes(Baseline to end of 12 and 24)
- Treatment emergent clinical and laboratory adverse events((TEAEs))
- Proportion of patients who require rescue medications(Baseline to end of 24 Weeks)
研究者
Dr Shubhadeep Sinha
Hetero Labs Limited