Biocon Reports Encouraging Results From Oral Diabetes Drug Study
Posted on: Tuesday, 9 September 2008, 12:00 CDT
India-based biotechnology company Biocon has announced the positive results of an ascending dose study with its oral insulin drug, IN-105.
The study involved dosing type 2 diabetes subjects with 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 the pharmacokinetics and pharmacodynamics of IN-105. The results showed that IN-105 was safe and well tolerated by patients.
Absorption of IN-105 was proportional to the dose administered; a serum average Cmax of 350 milliunits /litre 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 postprandial glucose rise over baseline for the 10, 15, 20 and 30mg doses were 15.3, 24.1, 31.3 and 49.5mg/dl lower than the corresponding rise for placebo.
Longer term, six month, studies are being planned in type 2 diabetic subjects to understand the impact of chronic dosing of IN-105 on postprandial glucose control and glycated haemoglobin.
Source: Datamonitor
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