Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Liraglutide: Liraglutide Injection 6.0 mg/ml manufactured by Levim Biotech
Dose - 1.2 mg/day via SC for the duration of 6 months
Control Intervention1: Liraglutide (Victoza): Liraglutid
Sponsors
Levim Biotech
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the HbA1c% from baseline compared to Victoza®Timepoint: 27 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean changes in fasting plasma glucose (FPG) and Post-prandial blood sugar (PPBS) from baseline to week 24 compared to Victoza® 2. Occurrence of clinical Adverse Events (AE) and serious AE (SAE) per System Organ Class (SOC) related to Liraglutide biosimilar or Victoza® 3. Clinical chemistry, haematology, urine analysis and other laboratory findings. 4. Incidence of hypoglycemic episodes compared to Victoza®Timepoint: 27 weeks | — |
Countries
India
Contacts
Public ContactNazia Sulthana DKS
Levim Biotech
Outcome results
None listed