A Prospective, Randomized, Open Label, Multi-Centre, Parallel Arm, Comparative Study with Blinded Assessment to Test the Non-inferiority of Liraglutide Biosimilar with Victoza in Patients with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 17
- 主要终点
- Reduction in the HbA1c% from baseline compared to Victoza®
研究概览
简要总结
This study is a Prospective, Randomized, Open Label, Multi-Centre, Parallel Arm, Comparative Study with Blinded Assessment to Test the Non-inferiority of Liraglutide Biosimilar with Victoza® in Patients with Type 2 Diabetes Mellitus. The primary objective of this study is to assess the reduction in the HbA1c% from baseline profiles of Biosimilar Liraglutide injection in a pre-filled pen 6 mg / mL of Levim Biotech [Test Product (A)] with Victoza® (Liraglutide) injection in pre-filled pen 6 mg / mL [Reference Product (B)]. The secondary objective of the study is to assess the mean changes in fasting plasma glucose (FPG) and Post-prandial blood sugar (PPBS) from baseline compared to Victoza®, Occurrence of clinical Adverse Events (AE) and serious AE (SAE) per System Organ Class (SOC) related to Liraglutide biosimilar or Victoza®, Clinical chemistry, haematology, urine analysis and other laboratory findings and Incidence of hypoglycemic episodes compared to Victoza®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide the written informed consent
- •Type 2 diabetes mellitus based on the disease diagnostic criteria provided by World Health Organization (WHO) or American Diabetes Association (ADA) guidelines
- •Male and female adult patients, at an age of 18-65 years, both inclusive
- •Hemoglobin level of ≥ 10 g/dL
- •Women of childbearing potential should agree to use suitable method of contraception throughout the study
- •Ability and willingness to take daily injections to abdomen, thigh or upper arm
- •Ability and willingness to adhere to the protocol requirements.
排除标准
- •Type 1 diabetes mellitus
- •Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness, or positive HIV seropositivity at screening
- •Known active or chronic hepatitis B or hepatitis C infection, or Hepatitis B and Hepatitis C seropositivity at screening, if not related to vaccination
- •History of or ongoing cardiac dysrhythmias requiring treatment, such as uncontrolled atrial fibrillation
- •Received Liraglutide or any other GLP-1 analogue treatment in the past
- •Known hypersensitivity reaction to GLP-1 analogue or any of the product components
- •Any active malignancy within 5 years prior to screening
- •Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol
- •Pregnant women or women planning to be pregnant or breast-feeding mothers.
结局指标
主要结局
Reduction in the HbA1c% from baseline compared to Victoza®
时间窗: 27 weeks
次要结局
- 1. Mean changes in fasting plasma glucose (FPG) and(Post-prandial blood sugar (PPBS) from baseline to)