Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Oral Insulin Spray: Titrated dose BD
Duration - 90 Days
Control Intervention1: Oral Insulin Spray and Metformin: Titrated dose morning and Tab. Metformin 500 mg in the evening
Duratio
Sponsors
Niedlfree Technologies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent signed 2. Adults of both sex aged greter than equal to 18 and less than equal to 60 years 3. BMI greter than equal to 18 and less than equal to 33 kg/m2 4. Patients diagnosed with T2DM since more than 1 year 5. Fasting Blood Glucose greter 126mg/dL & less than 200mg/dL 6. Glycated hemoglobin HbA1c greter than equal to 7 and less than equal to 10 % at screening visit 7. Patients with total daily insulin less than equal to 30 insulin units 8. No severe hypoglycemic or ketoacidosis episode requiring third-party intervention within the past 12 months
Exclusion criteria
Exclusion criteria: 1. Subjects with Type 1 Diabetes Mellitus and C peptide less than one nanogram per milliliter. 2. Refusal or inability to provide informed consent. 3. Participation in or administration of any clinical trials or investigational drugs within thirty days before the screening visit. 4. Presence of clinically significant endocrine disease, except euthyroid subjects on stable thyroxine therapy for at least three months prior to screening. 5. Presence of Type 1 diabetes. 6. Any clinically significant condition that might interfere with the evaluation of study medication. 7. Presence or history of cancer within the past five years. 8. Subjects with Type 1 Diabetes Mellitus and C peptide less than one nanogram per milliliter, refusal or inability to provide informed consent, participation in or administration of any clinical trials or investigational drugs within thirty days before the screening visit, clinically significant endocrine disease (except euthyroid subjects on stable thyroxine therapy for at least three months prior to screening), Type 1 diabetes, any condition that might interfere with the evaluation of study medication, presence or history of cancer within the past five years, laboratory abnormalities (including C peptide less than one nanogram per milliliter, positive urine pregnancy test in females of childbearing potential. 9. Any relevant abnormality that interferes with efficacy or safety assessments during study drug administration. 10. Laboratory abnormalities include C peptide less than one nanogram per milliliter, a positive urine pregnancy test in females of childbearing potential at screening, abnormal serum thyrotropin levels at screening, a positive test for hepatitis B surface antigen or hepatitis C antibody at screening, and glycated hemoglobin (HbA1c) less than ten percent at screening. 11. Antidiabetic drugs other than metformin within three months prior to screening. 12. Thyroid preparations or thyroxine within three months prior to screening. 13. Systemic long-acting corticosteroids within two months or prolonged use of other systemic corticosteroids or inhaled corticosteroids (daily dosage less than one thousand milligrams equivalent beclomethasone) within thirty days prior to screening. 14. Pregnancy or breastfeeding. 15. History of drug or alcohol abuse or addiction within the past five years. 16. Current tobacco use of more than ten cigarettes per day or equivalent. 17. History of skin diseases such as generalized eczema, lichen planus, or psoriasis. 18. Known allergy to some insulins. 19. Clarkes score greater than or equal to four 20. Severe late complications of diabetes, including severe neuropathy, nonstabilized proliferative retinopathy, estimated glomerular filtration rate less than fortyfive milliliters per minute, myocardial infarction, or stroke within the last three months. 21. Severe late complications of diabetes, including severe neuropathy, non-stabilized proliferative retinopathy, estimated glomerular filtration rate less than forty-five milliliters per minute, myocardial infarction, or stroke within the last three months. 22. Planned travel within fifteen days of the study. 23. Persons under guardianship or incapable of judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of oral Insulin administered as a liquid oral spray in the study participantsTimepoint: Day -3, Day 1, Day 14, Day 30, Day 60, Day 90, Day 97 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with treatment emergent AEs TEAEs and laboratory abnormalities 2. Proportion of participants with TEAEs leading to study treatment discontinuation 3. Rate of adverse events 4. To assess the glucose maintenance by administering oral Insulin in place of injectable insulin 5. To assess the effect of Oral Insulin on HbA1C levelsTimepoint: Day -3, Day 1, Day 14, Day 30, Day 60, Day 90, Day 97 | — |
Countries
India
Contacts
Public ContactMs.Sathyavathi L M
Samahitha Research Solutions
Outcome results
None listed