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Ten Thousand Patients Using Levemir Insulin Show Improvements in BG Without Weight Gain

Posted: Thursday, June 15, 2006

Levemir reduced mean A1C levels by 0.54 percent for type 1 and 0.89 percent for type 2 diabetes patients.

Novo Nordisk announced results from the German cohort of 10,276 patients enrolled in the observational PREDICTIVE(TM) trial, which found Levemir(R) (insulin detemir [rDNA origin] injection) improved blood sugar control (A1C) and reduced episodes of major hypoglycemia (low blood sugar) with no weight gain in actual clinical practice. The primary endpoint was safety.

In PREDICTIVE, Levemir demonstrated significant improvement in blood sugar control - A1C levels were reduced significantly in both type 1 and type 2 diabetes patients. In addition, patients with type 2 diabetes lost weight, while type 1 patients maintained their weight while using Levemir. Weight gain is a common side effect of insulin therapy(1) and Levemir is the first insulin to show less weight gain versus other basal insulins in 12 of 12 controlled clinical trials. Among people with diabetes, 90 to 95 percent have type 2 diabetes(2) and 80 percent of people with diabetes are overweight or obese(3).

Additionally, an analysis of a sub-group of this study of type 2 diabetes patients (n=511) focused on patients who switched from NPH or glargine to Levemir. These patients experienced significant improvement in A1C, and reduced episodes of major hypoglycemia. Both patient groups also experienced weight reduction.

Source: Diabetes In Control: PREDICTIVE Study Key Findings (Poster# 511-P) These results and the findings of a separate sub-group analysis were presented at the 66th Scientific Sessions of the American Diabetes Association in Washington, D.C.