A study to comparative non-inferiority of Liraglutide Biosimilar with Victoza in Type II Diabetes patients
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2022/02/040261
- Lead Sponsor
- Levim Biotech
- Brief Summary
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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 256
- 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.
- 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 patient’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
- Primary Outcome Measures
Name Time Method Reduction in the HbA1c% from baseline compared to Victoza® 27 weeks
- Secondary Outcome Measures
Name Time Method 1. Mean changes in fasting plasma glucose (FPG) and Post-prandial blood sugar (PPBS) from baseline to
Trial Locations
- Locations (17)
Crescent Hospital & Heart center
🇮🇳Nagpur, MAHARASHTRA, India
DEC-Health Care Hospital
🇮🇳Nellore, ANDHRA PRADESH, India
Endolife Speciality Hospital Pvt Ltd
🇮🇳Guntur, ANDHRA PRADESH, India
Government Medical College
🇮🇳Kozhikode, KERALA, India
KG Hospital, A Unit of K.Govindaswamy Naidu Medical Trust
🇮🇳Coimbatore, TAMIL NADU, India
Kurnool Medical College
🇮🇳Kurnool, ANDHRA PRADESH, India
Mar Augustine Golden Jubliee Hospital (MAGJ)
🇮🇳Ernakulam, KERALA, India
Nehru hospital, PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Nirmal Hospital Private Limited
🇮🇳Surat, GUJARAT, India
Noorul Islam Institute of Medical Sciences, and Research Foundation
🇮🇳Thiruvananthapuram, KERALA, India
Scroll for more (7 remaining)Crescent Hospital & Heart center🇮🇳Nagpur, MAHARASHTRA, IndiaDr Kashif SayedPrincipal investigator8007053786drkasyed@gmail.com