Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: USVCAP: The investigational product, USVCAP will be administered at doses 75 IU, 150 IU, and 300 IU, orally, twice daily
Control Intervention1: Not applicable: Not applicable
Sponsors
USV Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged 35 to 60 years (both inclusive) 2. Type 2 diabetes mellitus diagnosed 3. Glycated haemoglobin level = 7% and = 9.5% 4. On stable oral monotherapy with metformin hydrochloride (1000 mg to 2500 mg/day) and regular diet and exercise regimen at least 12 weeks prior to enrolment 5. Body mass index between 18 to 30 kg/m2 6. Ability to perform capillary blood glucose measurements 7. Willing to provide informed and written consent for the clinical trial. 8. Able to comply with all requirements of clinical Trial protocol as per investigator opinion.
Exclusion criteria
Exclusion criteria: 1. Subject with history or evidence of hypersensitivity to insulin or metformin hydrochloride or its excipients 2. Suffering from type 1 diabetes mellitus 3. Received treatment with sulphonylureas or alphaglucosidase inhibitors, Glucagon-like peptide-1 (GLP-1) receptor agonists or Sodium-glucose co-transporter 2 (SGLT2) inhibitors or meglitinides or pramlintide or thiazolidinediones within 3 months prior to enrolment 4. Previously treated with insulin within 3 months prior to enrolment 5. History of episodes of hypoglycaemia during 3 months prior to enrolment. 6. Reduced awareness of hypoglycaemia or inability to identify and tackle hypoglycaemic episodes as per investigator’s discretion 7. History of substantial weight loss defined as 5% decrease in body weight within the last 6 months. 8. Medical history of unstable angina within 1 year prior to enrolment 9. History of tobacco or nicotine more than two packs/day within 3 months prior to enrolment. 10. Is, at the time of signing informed consent, a user of recreational or illicit drugs or had a recent history (within 1 year prior to enrolment) of drug or alcohol abuse or dependence. (Note: Alcohol abuse includes heavy alcohol intake as defined by >3 drinks per day or >14 drinks per week, or binge drinking). 11. History of gastrointestinal disorders which may potentially interfere with absorption of the IP 12. Treatment with systemic corticosteroids or with inhalational corticosteroids (Beclomethasone or budesonide) within the 3 months prior to enrolment 13. Likelihood of requiring treatment during the study period with prohibited medications mentioned (as defined in this clinical trial protocol) 14. Female subject who is pregnant, lactating or planning pregnancy during the proposed course of the trial 15. Female subject of childbearing age who is not willing to use adequate method/s of contraception during the study period 16. Life expectancy of less than 6 months from screening as per investigator’s discretion 17. Elective surgery or any other surgical procedure/s requiring general anaesthesia during the clinical trial 18. Has participated in another research trial within 12 weeks prior to screening 19. History of diabetic ketoacidosis requiring hospitalization within 6 months prior to enrolment, case of proliferative retinopathy or advanced neuropathy 20. Subject having the any of the following laboratory results at screening a. Estimated glomerular filtration rate (eGFR) a. Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) >3 times of upper limit normal b. Blood urea nitrogen (BUN) > 30 mg/dL 21. Subject who has a positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections at screening 22. Subject who has undergone pancreatectomy or pancreas islet transplant or renal transplant. 23. Subject receiving or has received any immunomodulation medications within 1 year prior to enrolment 24. Subject with history or evidence of diabetic complications (e.g. diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy, etc.), cardiac disorders, or any other systemic complication due to diabetes, which in the opinion of the investigator signifies subject’s ineligibility for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycated hemoglobin (HbA1c) levelTimepoint: post 12-week administration of selected fixed dose of USVCAP | — |
Secondary
| Measure | Time frame |
|---|---|
| 5. To assess the immunogenicity of the investigational productTimepoint: 12 weeks & 16 weeks;Change in FPG and 2-hour PPG levels in each treatment group post 12-week treatment with USVCAPTimepoint: 12 weeks;Change in laboratory investigations post 12-week treatment with USVCAPTimepoint: 12 weeks;Comparison of change in HbA1c between the 3 fixed dose levels studied to examine dose response relationship post 12-week treatment with USVCAPTimepoint: 12 weeks;Treatment emergent adverse events (TEAEs) that occur during the study period, including hypoglycemic episodes in each treatment groupTimepoint: 9 months | — |
Countries
India
Contacts
Public ContactDr Gajanan Sudhir Namjoshi
USV Private Limited
Outcome results
None listed