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Type 1 Diabetics May Gain Disease Control Through Transdermal Insulin Patch: Presented at IDF

By Ed Susman

PARIS, FRANCE -- Aug. 27, 2003 -- An investigative insulin patch, held in place with bands, appears to help patients achieve diabetes control, researchers reported Tuesday in a poster presentation here at the 18^th International Diabetes Foundation Congress.

"Our findings suggest that the transfer of monomeric insulin molecules through the intact human skin for potential therapeutic use is possible," said Ines Baotic, MD, physician/scientist, Vuk Vrhovac Institute, University Clinic for Diabetes, Endocrinology and Metabolic Diseases, University of Zagreb, Croatia.

Dr. Baotic and colleagues recruited 43 patients with Type 1 diabetes for the study, which was undertaken with the support of TransDermics Ltd., Ashdod, Israel.

"The transdermal route of insulin delivery has been a very challenging option due to its lack of proteolytic enzymes," said Dr. Baotic. Although successful in animal models, use of the transdermal route in humans has been frustrated by the size of the insulin molecule. The new formulation of genetically engineered human monocomponent insulin with a microemulsion vehicle, however, appears to work in getting through the human skin.

In this crossover study, patients wore the patch for eight hours. The testing took place in a hospital setting so the patients could be carefully monitored over three days. Blood glucose monitoring was performed in 15-minute intervals. If blood glucose levels exceeded 5.5 mM/L at 2-, 4- and 6-hour checkpoints, subcutaneous insulin supplements were allowed in individually determined doses.

Dr. Baotic noted that 22 patients on a patch containing 840 IU of insulin required an average of 1.82 IU of injected insulin to maintain metabolic control compared with 2.17 IU of injected insulin for the 21 patients on a placebo patch (P<0.05).

On the other hand, a patch saturated with 187.5 IU of insulin did not allow sufficient insulin to pass through the skin to significantly decrease the need for injected drugs.

Dr. Baotic stated that the 840 IU patch achieved effectiveness in lowering the need for injected insulin about two hours after being placed on the inner side of one upper arm. The patch then controlled diabetes for as long as it was left in place.

"There were no unexpected adverse events," Dr. Baotic said. "The patch appears safe and well-tolerated." She added, however, that more work needs to be accomplished before the transdermal insulin patch can be individualized for patient use.


[Study title: Transdermal insulin delivery system for potential therapeutic use to Type 1 diabetics. Abstract 2220]

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