Levemir demonstrates safety and efficacy

7 February 2007

Danish drugmaker Novo Nordisk says that the results of a trial of Levemir (insulin detemir [rDNA origin] injection) are a further indication of the drug's safety and efficacy. The study, which allowed patients with type 2 diabetes to self-adjust treatment dosage, showed that such action brought about an improvement in blood sugar levels comparable to that achieved by physician adjusted-dosing.

The findings, which were discussed at the American Diabetes Association's annual scientific meeting in Chicago, are derived from the US PREDICTIVE 303 trial, which recruited 5,604 participants with type 2 diabetes. Patients were randomized to either the Levemir self-adjustment group or the standard treatment group.

The results showed that A1C levels in the self-adjust group fell from a baseline average of 8.5% to 7.9% after 26 weeks, whereas A1C in the standard treatment arm were reduced from 8.5% to 8.0% over the same period. In addition, compared to baseline, fasting plasma glucose values dropped by 34mg/dl and 21mg/dl in the self- and physician-adjusted cohorts, respectively.

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