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

Delivering insulin in a pill

Given the choice of taking a pill or injecting oneself with a needle, most of us would opt to regulate a chronic health condition by swallowing a pill. But for millions o...

Can aspirin treat Alzheimer's?

A regimen of low-dose aspirin potentially may reduce plaques in the brain, which will reduce Alzheimer's disease pathology and protect memory, according to neurological r...

FDA approves first drug comprised of an active ing…

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms o...

Researchers develop a new method for turning skin …

Our bodies consist of many different kinds of cells, each with their own role. The Japanese scientist Shinya Yamanaka had made earlier the discovery, earning the Nobel Pr...

Some existing anti-cancer drugs may act in part by…

Bolstering the notion that RNA should be considered an important drug-discovery target, scientists at Scripps Research have found that several existing, FDA-approved anti...

Poliovirus therapy for recurrent glioblastoma has …

A genetically modified poliovirus therapy developed at Duke Cancer Institute shows significantly improved long-term survival for patients with recurrent glioblastoma, wit...

Human clinical trial reveals verapamil as an effec…

Researchers at the University of Alabama at Birmingham Comprehensive Diabetes Center have discovered a safe and effective novel therapy to reduce insulin requirements and...

Novartis Clear about Psoriasis survey data highlig…

Novartis announced today the publication of global Clear about Psoriasis survey data in the Journal of the European Academy of Dermatology and Venereology[1]. The publica...

New small molecules pave the way for treating auto…

The innate immune system is the first line of defense, with cells that quickly identify "foreign" motifs from viruses and bacteria and mount up a counterattack to elimina...

How targeting metabolism can defeat cancer stem ce…

Researchers are the University of Michigan Rogel Cancer are unraveling a crucial thread that explains why cancer so often becomes resistant to treatment. In a breakthroug...

Amgen and MBC Biolabs announce winners of the Amge…

Amgen (NASDAQ:AMGN) and MBC BioLabs (formerly QB3@953) announced that Delve Therapeutics and Mitokinin have won the Amgen Golden Ticket at MBC BioLabs. Each company recei...

FDA warns of imposters sending consumers fake warn…

The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or ove...