Novo Nordisk A/S (NVO) announced new data from a randomized, controlled, 26-week (with a 26-week extension), open-label, treat-to-target study (BEGIN YOUNG 1) on Tresiba for type I diabetes in children and adolescents (aged 1 year to less than 18 years). Results showed that Tresiba plus insulin aspart effectively improved long-term glycemic control in the patients.
The study was conducted to evaluate the efficacy and safety of Tresiba (once daily) plus bolus insulin aspart in comparison with the company’s Levemir (insulin detemir) plus bolus insulin aspart.
At 26 weeks, Tresiba met the primary endpoint of non-inferiority to Levemir for average change in hemoglobin A1c. In the 26-week extension study, a lower insulin dose achieved a significantly higher reduction in fasting plasma glucose compared to Levemir. Patients administered Tresiba showed significantly lower rates of hyperglycemia (high blood glucose) with ketosis.
However, treatment with Tresiba plus insulin aspart caused higher incidences of severe hypoglycemia (abnormally low blood glucose) than Levemir plus insulin aspart.
Novo Nordisk stated that this is the first study to assess the long-term safety of Tresiba in patients (between 1 year and <18 years) suffering from type I diabetes.
The above data was presented at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD).
Tresiba is already available in Denmark for patients suffering from type I and type II diabetes. It is also approved in the EU and select European countries, Brazil, Mexico, Japan and Russia among others.
We remind investors that Tresiba is also being evaluated in the DEVOTE study for additional cardiovascular data on the candidate. Patient enrollment in the study should be completed by Feb 2015. The company intends to file a new drug application for Tresiba in the first half of 2015.
We are encouraged by Novo Nordisk’s progress with its diabetes pipeline.
Novo Nordisk carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceutical sector are Allergan Inc. (AGN), Mallinckrodt plc (MNK) and Lannett Company, Inc. (LCI). All these stocks carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment