Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: VBLG01: Dose:
â?¢ Liraglutide will be started at dose of 0.6 mg daily by subcutaneous injection to improve gastrointestinal tolerability
â?¢ After at least 1 week dose increased to 1.2 mg/day for a duration of at least 1 week and there after dose maintained at 1.2 mg / day or increased to 1.8 mg / day depending on glycemic control.
ROA
Sponsors
Virchow Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 18 â?? 65 years. 2. Patients with Type 2 diabetes treated with oral antidiabetic drugs (OADs) like metformin and/or sulfonylureas and/or alpha glucosidase inhibitors and/or sodium-glucose co-transporter 2 (SGLT2) inhibitors at stable dose for at least 3 months before screening. 3. Patients with glycosylated hemoglobin >=7 to 4. Patients with a body mass index of greater than or equal to 23 kg/m2 and less than or equal 45 kg/m2. 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.Patients with significant liver, cardiac or gastrointestinal disease. 2.Hypersensitivity to liraglutide or any component of the formulation. 3.Insulin treatment during the previous 3 months - except short-term treatment for intercurrent illness. 4.Impaired liver function - (ALT, AST, ALP concentrations greater than or equal to 2·5 times upper normal range. 5. Impaired renal function - eGFR lessthan 60 mL/min/1.73 m2). 6.Uncontrolled hypertension greater than or equal to160/100 mm Hg. 7.Malignancy. 8.Used any drugs apart from OGLAs likely to affect glucose concentrations, including androgens, hyperglycaemia-associated agents, hypoglycaemia-associated agents, MAO inhibitors, quinolone antibiotics, salicylates -Anti-inflammatory dose. 9.Treatment with dipeptidyl peptidase 4 inhibitors. 10.Treatment with systemic corticosteroids. 11.History or family history of medullary thyroid carcinoma. 12.Multiple endocrine neoplasia syndrome type 2. 13.History of pancreatic cancer and pancreatitis. 14.History of recent MI, uncontrolled CHF, and unstable angina. 15.History or known case of severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy. 16.Pregnancy. 17.Previous exposure to exenatide or liraglutide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in reduction in the HbA1c from baseline to 24 weeksTimepoint: Mean change in reduction in the HbA1c from baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean change in fasting plasma glucose (FPG) from baseline to 24 weeks. 2.Mean change in post-prandial blood sugar (PPBS) from baseline to 24 weeks. 3.Percentage of subjects with HbA1c less than 7% at 24 weeks. 4.Percentage of subjects with HbA1c less than or equal to 6.5% at 24 weeks. 5.Change in body weight from baseline to 24 weeks. 6.Incidence and severity of hypoglycaemic events. Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed