CTRI/2022/02/040261已完成3 期
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 - DIABLESS
evim Biotech0 个研究点目标入组 256 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Willing to provide the written informed consent
- •2. Type 2 diabetes mellitus based on the disease
- •diagnostic criteria provided by World Health
- •Organization (WHO) or American Diabetes
- •Association (ADA) guidelines
- •3. Male and female adult patients, at an age of 18-65 years, both inclusive
- •4. Hemoglobin level of >= 10 g/dL
- •5. Women of childbearing potential should agree to use suitable method of contraception throughout the study
- •6. Ability and willingness to take daily injections to abdomen, thigh or upper arm
- •7. Ability and willingness to adhere to the protocol requirements
排除标准
- •1. Type 1 diabetes mellitus
- •2. Known to be human immunodeficiency virus (HIV)
- •positive or have an acquired immunodeficiency
- •syndrome-related illness, or positive HIV
- •seropositivity at screening
- •3. Known active or chronic hepatitis B or hepatitis C infection, or Hepatitis B and Hepatitis C seropositivity at screening, if not related to vaccination
- •4. History of or ongoing cardiac dysrhythmias requiring treatment, such as uncontrolled atrial fibrillation
- •5. Received Liraglutide or any other GLP-1 analogue treatment in the past
- •6. Known hypersensitivity reaction to GLP-1 analogue or any of the product components
- •7. Any active malignancy within 5 years prior to
- •8. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patientâ??s safety or compliance with the protocol
- •9. Pregnant women or women planning to be pregnant or breast-feeding mothers
研究者
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