Indian biopharmaceutical company Biocon has teamed up with JDRF to test oral insulin on people with type 1 diabetes.
JDRF has funded the testing of Insulin Tregopil, which has been designed in the form of a pill, to evaluate its safety and tolerability in a new trial.
Oral insulin has experienced a number of developmental stumbling blocks as, despite being more convenient and safe, the insulin rapidly degrades in the stomach, rendering oral consumption ineffective.
But Biocon is confident that Insulin Tregopil, a new formulation of insulin, can improve postprandial (after meal) blood glucose levels and hold the potential to transform type 1 diabetes management.
The new trial will involve multiple ascending doses of Insulin Tregopil being tested against therapeutic doses of NovoRapid (insulin aspart), made by Novo Nordisk.
Biocon are hoping the findings will build on positive clinical data from 2016 phase I trials where the drug was shown to have a faster action compared to other bolus insulins.
“With this proposed clinical study, we hope to build on the extremely promising data that we have generated so far through previous human trials with Tregopil,” said Biocon CMD Kiran Mazumdar-Shaw.
“We are committed to addressing the huge unmet need of people with diabetes by providing the medical community an alternate treatment for postprandial hyperglycaemia.”
Esther Latres, JDRF Director, Translational Development, added: “JDRF has been supportive of oral insulin studies to help people with type 1 diabetes better manage their glucose levels with less need for injected insulin.
“To achieve that goal would be one incredible step toward improving the quality of life for people with T1D while we strive for our ultimate goal of a cure.”
Biocon has also filed a Clinical Trial Application with Indian drug regulator DCGI for phase II and III studies to test Insulin Tregopil in type 2 diabetes.