A study to comparative non-inferiority of Liraglutide Biosimilar with Victoza in Type II Diabetes patients

Phase 3

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2022/02/040261
• Lead Sponsor: evim Biotech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-21
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 256

Inclusion Criteria

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

Exclusion Criteria

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

screening

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified