Melbourne, Australia-based Phosphagenics says that it has commenced a Phase I clinical trial of its transdermal insulin delivery product, TPM- 02/Insulin, which is being developed as a novel way of administering insulin to diabetics, and this study follows on from the successful preclinical evaluations that were reported to the market earlier this year.
The primary objective of this study is to assess the safety and tolerability of this administration platform in delivering insulin through the skin. Blood glucose and insulin levels will also be measured as secondary outcomes. In the proposed study, 20 healthy male volunteers aged between 18 and 45 will be randomly assigned to receive either TPM-02/Insulin or a placebo gel, applied in a single dose directly to the skin. Patients will then be monitored for a period of 48 hours.
The trial, which is being conducted at the Alfred Hospital in Melbourne, in accordance with international standards, is expected to be completed by the end of July, with a full analysis anticipated by September 2006.
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