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

Novo Nordisk: Levemir improves blood-sugar control, may halt weight gain for diabetics

By Elaine Rigoli

Tampa, Fla., June 12 - Novo Nordisk released data from the observational Predictive trial, which found Levemir (insulin detemir [rDNA origin] injection) 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. The primary endpoint was safety.

Weight gain is a common side effect of insulin therapy, and Levemir is the first insulin to show less weight gain versus other basal insulins in 12 of 12 controlled clinical trials, according to a news release.

Among people with diabetes, 90% to 95% have type 2 diabetes and 80% of diabetics are overweight or obese, the release said.

Study findings showed:

• Levemir reduced mean A1C levels by 0.54% for type 1 and 0.89% for type 2 diabetes patients;

• Episodes of major hypoglycemia were significantly reduced in type 1 patients and as well as type 2 patients. In type 1 patients, major hypoglycemic episodes dropped from 1.08 per patient year in the four weeks prior to study start to 0.12 per patient year in the four weeks before follow-up. In type 2 patients, major episodes dropped from 0.3 to 0.06 per patient year;

• Twenty eight serious adverse drug reactions were reported during the follow up period of 14.5 weeks, the majority of which were hypoglycemic episodes;

• Type 1 patients gained no weight and type 2 patients experienced a slight reduction in body weight during the study;

• 73% of type 2 patients used Levemir once daily.

New York-based Novo Nordisk is a health care company focused on diabetes care.


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