Biocon reports on oral insulin trial

India's Biocon announced the results of an ascending dose study with its oral insulin drug IN-105 at the European Association for the Study of Diabetes meeting in Rome, Italy.

The study involved patients with type 2 diabetes being given single doses of 0mg (placebo), 10mg, 15mg, 20mg and 30mg tablets of IN-105 in five separate periods before a mixed 600kcal breakfast. The outcome measurements were the safety and tolerability of IN-105, as well as its pharmacokinetics and pharmacodynamics. The firm says the results showed that the drug was safe and well tolerated by patients.

Absorption of IN-105 was proportional to the dose administered; a serum average Cmax of 350milliunits/liter was reached at 30 minutes post dosing at the highest dose of 30mg. The resulting glucose drops showed linearity with respect to the dose. The two-hour post-prandial glucose rise over baseline for the 10mg, 15mg, 20mg and 30mg doses were 15.3mg/dL, 24.1mg/dL, 31.3mg/dL and 49.5mg/dL, respectively, lower than the corresponding rise for placebo.