New study first ever to directly compare once-daily Levemir® with another basal insulin analogue

Novo NordiskNovo Nordisk has 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 & Metabolism.

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.

About Novo Nordisk
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 www.novonordisk.com.

Most Popular Now

Novartis announces plan to initiate clinical trial…

Novartis today announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the effic...

Gilead announces results from Phase 3 trial of inv…

Gilead Sciences, Inc. (Nasdaq: GILD) announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigation...

AstraZeneca and Oxford University announce landmar…

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine a...

Sanofi and Regeneron provide update on U.S. Phase …

Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the preliminary results from the Phase 2 portion of an ongoing Phase 2/3 trial evaluating Kevzar...

Roche's COVID-19 antibody test receives FDA Emerge…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) (1) for its new Elecsys® Ant...

Pfizer and BioNTech dose first participants in the…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 va...

Arthritis drug may improve respiratory function in…

A small study in Greece found that the clinically approved anti-inflammatory drug anakinra, used to treat rheumatoid arthritis, improved respiratory function in patients ...

Early indicators of vaccine efficacy

Ludwig-Maximilians-Universität (LMU) in Munich researchers have shown that a specific class of immune cells in the blood induced by vaccination is an earlier indicator of...

Frankfurt researchers discover potential targets f…

A team of biochemists and virologists at Goethe University and the Frankfurt University Hospital were able to observe how human cells change upon infection with SARS-CoV-...

Vitamin D linked to low virus death rate

A new study has found an association between low average levels of vitamin D and high numbers of COVID-19 cases and mortality rates across 20 European countries. The r...

Loss of smell associated with milder clinical cour…

Following an earlier study that validated the loss of smell and taste as indicators of SARS-CoV-2 infection, researchers at UC San Diego Health report in newly published ...

Can an existing HIV medication slow the spread of …

A team of scientists from St. Michael's Hospital, Sinai Health and Sunnybrook Health Sciences Centre have launched a clinical trial to understand whether an existing drug...