Mumbai: Biocon Ltd, the country's premier biotechnology company, today said the oral insulin IN-105 developed by the company is safe and well tolerated by patients.

The results of an ascending dose linearity study with the oral insulin drug (IN-105) were announced at the European Association for the Study of Diabetes (EASD) meeting in Rome on 8 September.

The study of the drug's tolerability involved dosing Type 2 diabetes subjects with single doses of 0 mg (placebo), 10 mg, 15 mg, 20 mg and 30 mg tablets of IN-105 in 5 separate periods before a mixed 600 kcal breakfast, the company said in a release.

The 2 hour postprandial glucose rise over baseline for the 10, 15, 20 and 30 mg doses were 15.3, 24.1, 31.3 and 49.5 mg/dL lower than the corresponding rise for placebo. There were no symptomatic hypoglycemic events observed at any of the doses.

The results showed that IN-105 is safe and well tolerated by Type 2 diabetic patients and is able to significantly drop 2-hour post-prandial glucose in a dose-related manner, the release said.

The oral insulin, which aims to be a needleless alternative to the injection, has advanced to late-stage trials, having shown promising results in the mid-stage studies in India.

Dose linearity essentially means the response of the drug is proportional to the units consumed, an important parameter in its predictability. This study clearly demonstrated a near-perfect linear dose response, which is most encouraging, said Kiran Mazumdar-Shaw, chairman and managing director of Biocon.

Additionally, a significant two-hour post-prandial glucose drop has been seen, which indicates that IN105 has potential in demonstrating efficacy in longer-term trials, she added.

However, what will really determine its clinical efficacy is the next study that will have HbA1c (a measure of blood sugar control over three months) as the end point, says Harish Iyer, head (research and development) at Biocon.

''The present study shows that IN105 delivers physiologically active insulin orally in concentrations sufficient to decrease post-meal hyperglycemia and to decrease the burden of the meal on endogenous insulin secretion. These data support the feasibility of providing insulin orally to treat postprandial hyperglycemia in diabetic patients'' affirmed Dr Harold E Lebovitz, MD, FACE, professor of medicine, endocrinology and diabetes at the State University of New York Health Science Center at Brooklyn.

''The data presented here show that insulin can be reliably delivered in individuals with type 2 diabetes via the oral route. Further the administered insulin improved control post meal plasma glucose without causing symptomatic hypoglycemia. Such data support the feasibility of oral insulin delivery as a therapeutic option'' said Prof Alan D Cherrington, PhD, professor of molecular physiology & biophysics, professor of medicine, Vanderbilt University.

IN-105 is a novel analog of insulin, proprietary to Biocon. The product has special properties that make it feasible for delivery in tablet form stable at room temperature. Besides being a needle-free insulin, this method of delivery allows IN-105 to be delivered into the body in a physiological manner that mimics the way that the pancreas release insulin into the circulation (i.e. into the portal vein). This contrasts with all the other known methods of delivery, including inhaled insulin, which brings in insulin from the periphery into the circulation.

Biocon Limited is India's pioneer biotechnology enterprise established in 1978. Biocon and its two subsidiaries, Syngene and Clinigene form a fully integrated biotechnology enterprise, with specialized focus on biopharmaceuticals, contract research and clinical research.

Biocon has acquired a majority stake in the German pharmaceutical company, AxiCorp, have given Biocon wider global access and greater market penetration.