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Published on 6/12/2006 in the Prospect News Biotech Daily.

Sanofi-Aventis study shows algorithm as effective as mealtime insulin dosing in type 2 diabetes

By Lisa Kerner

Charlotte, N.C., June 12 - Sanofi-Aventis said results from a new study found that a simple algorithm to adjust mealtime insulin based on pre-meal glucose patterns is as effective as the standard, more complex carbohydrate counting method.

The new method may provide patients with an easier alternative to dose their mealtime insulin therapy, according to a company news release.

In the 24 week, open-label randomized study of 273 patients, those using both the new mealtime dosing algorithm and the traditional carbohydrate counting method achieved mean A1C levels of 6.6%, within the recommended blood sugar control target of less than 7%.

At the end of 24 weeks, A1C was significantly reduced in both study arms to 6.6% from 8.2% with no difference between the algorithm and carbohydrate counting groups, respectively.

However, the algorithm group received significantly higher doses of glulisine and glargine, with significantly less symptomatic hypoglycemia events than the carbohydrate-counting group.

The basal/bolus regimens like the glulisine/glargine combination used in the study simulate the normal physiologic insulin response in people without diabetes. Many people with type 2 diabetes could benefit from such a regimen, officials said.

"This new dosing approach relies on a simple algorithm that allows patients to start with a fixed dose of mealtime glulisine and then adjust to target based on premeal glucose patterns," study author Richard M. Bergenstal said in the release.

"This is an easy way to dose and adjust mealtime insulin that should meet the needs of many patients who are not prepared to undertake the equally effective but more complex carbohydrate counting method.

The study data were presented at the American Diabetes Association's 66th Annual Scientific Sessions in Washington, D.C.

Paris-based Sanofi-Aventis develops products used in therapeutic areas including cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines.


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