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Novo Nordisk today announced the first patient visit in a new head-to-head clinical trial of once-daily Levemir® against insulin glargine. This study is the first time the two basal insulins will be directly compared in an exclusively once-daily regimen. Outcomes measured in the study will include efficacy, effect on weight and hypoglycaemia in type 2 diabetes patients.

“This is the first study of its kind to directly compare once-daily Levemir® with insulin glargine, and the results will be important for both physicians and patients. It will help them to understand the comparative benefits of both insulins and choose the best treatment option,” said Christoph Koenen, MD, MBA, corporate vice president, Global Medical Affairs at Novo Nordisk. “Previous studies have indicated that once-daily Levemir® provides a 24-hour duration of action, HbA1c reductions equal to insulin glargine and in addition has the benefit of less weight gain than other insulin therapies.”

The study, called EFFICACY™, will involve more than 430 patients internationally, including 314 in the United States. It follows the newly released positive outcomes from the TITRATE™ study, just published in Diabetes, Obesity & Metabolism1.

The TITRATE™ study evaluated the benefits of type 2 diabetes patients managing their insulin dose themselves to reach one of two predetermined glucose targets. Approximately 60% of patients in the trial achieved an HbA1c of =7%, as recommended by the American Diabetes Association, and these improvements were not compromised by significant weight gain.

“For many patients, the administration of insulin represents a number of challenges, including fear of hypoglycaemia and weight gain,” added Koenen.  “However, by allowing patients to take control of their dosing to reach HbA1c targets, better compliance can be achieved. The TITRATE™ study shows that once-daily Levemir® allows patients to do this and maintain optimal control over their condition.”

New data for once-daily Levemir® will be presented at the 69th Annual Meeting on the American Diabetes Association. This will include results from the PREDICTIVE™ study, and data exploring the potential of Levemir® use in children and adolescents.

About Levemir® (insulin detemir [rDNA origin] injection)

Levemir® 100 U/ml solution for injection in a cartridge (Penfill®). Levemir® 100 U/ml solution for injection in a prefilled pen (FlexPen®).

Active substance: insulin detemir. Composition: active pharmaceutical ingredient: 100 U/ml insulin detemir, genetically produced from recombinant DNA in Saccharomyces cerevisiae. Excipients: glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, water for injections. Therapeutic indications: diabetes mellitus. Method of administration: In combination with oral antidiabetic medicines it is recommended to use Levemir® once daily, initially at a dose of 10 U or 0.1-0.2 U/kg. Levemir® 100 U/ml solution for injection has been developed for use with the Novo Nordisk insulin injection systems and NovoFine® or NovoTwist® injection needles. NovoFine® or NovoTwist® injection needles 8 mm in length or shorter are provided for use with Levemir® in FlexPen®.

Contraindications: Hypoglycaemia, hypersensitivity to insulin detemir or any of the excipients. No data is available on the clinical use of insulin detemir during pregnancy or when breastfeeding. Caution is recommended when using this product during pregnancy or when breastfeeding. Undesirable effects: Hypoglycaemia, visual disturbances or oedema upon initiation of treatment. Reactions at the injection site (redness, swelling, inflammation, itching and bruising). Lipodystrophy at the injection site if injected too frequently into the same place. Allergic reactions, potentially allergic reactions, urticaria and rashes; very rarely, generalised hypersensitivity reactions, which may be life-threatening. Rarely, neuropathy in the arms and legs during fast improvement of blood glucose control. Prescription-only medicine.

Levemir® is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 27,900 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For more information, visit novonordisk.com.

Further information:

Reference

1. L. Blonde et al. Patient directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets – the TITRATE™ Study. Diabetes, Obesity and Metabolism 2009; 11:6 623-631