Biocon's trials of oral insulin fails primary test

Biocon said that the tests conducted for its experimental oral insulin, IN-105, have not met their primary end point. The company may continue its development with a global partner. Initial data analysis of the test showed that IN-105 did not meet its primary end point of lowering HbA1c levels by 0.7%, compared to a placebo. HbA1c is a test that measures the amount of glycated haemoglobin in the blood. Glycated haemoglobin levels indicate the effectiveness of a drug to control blood sugar levels.




On secondary safety endpoints, IN-105 showed excellent overall safety profile with no incidence of serious adverse events, Biocon said in a statement. Kiran Mazumdar-Shaw, managing director and chairman, said, "Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner."

The company added that post-hoc analyses of self-monitored blood glucose levels in the IN-105 arm and the placebo arm indicated large reductions in pre-meal glucose levels in the placebo arm, which strongly suggested behavioural modification among patients, and which might have affected the primary outcome.