Welcome!

News Feed Item

Tresiba® and Victoza® Receive Positive Opinions From CHMP for Label Updates Expanding Indications for Use in Adults With Type 2 Diabetes

COPENHAGEN, March 21, 2014 /PRNewswire/ --

FOR MEDICAL MEDIA ONLY

NOT INTENDED FOR US OR UK MEDIA

The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for expanded use of Tresiba® (insulin degludec) and Victoza® (liraglutide) in type 2 diabetes. Once the European Commission approves the label expansion, physicians will be able to prescribe Tresiba®, the once-daily, long-acting basal insulin in combination with GLP-1 receptor agonists, such as Victoza®. Similarly, Victoza®, the once-daily human glucagon-like peptide-1 (GLP-1 analogue), can be prescribed in combination with a basal insulin.

     (Logo: http://photos.prnewswire.com/prnh/20120911/559804 )

Tresiba® was approved in Europe in 2013 for once-daily use in adults with type 1 and type 2 diabetes as a monotherapy and in combination with oral anti-diabetic (OAD) medicinal products or with mealtime insulin[1]. Victoza® was approved in Europe in 2009 for the treatment of type 2 diabetes in adults in combination with OADs[2].

"This is excellent news for patients with type 2 diabetes and their physicians. The update expands the options physicians have to individualise therapy for their patients and help them achieve glycaemic targets, especially if they have concerns about hypoglycaemia and weight gain," said Professor Chantal Mathieu, Katholieke Universiteit Leuven, Belgium, the lead study investigator of the BEGIN: VICTOZA® ADD-ON trial.

The CHMP recommendation for both Tresiba® and Victoza® was based on efficacy and tolerability data from four phase 3 clinical trials[3]-[6]. All four trials were conducted in adults with type 2 diabetes.

About the studies

Pivotal data came from the BEGIN: VICTOZA® ADD-ON[3] 26-week open-label extension to a 104-week clinical trial in which 57% of patients treated with Tresiba® in combination with metformin achieved a target HbA1c <7%. Patients who did not achieve the HbA1c target were randomised to receive either a single dose of NovoRapid® (insulin aspart), with the largest meal or once-dailyVictoza® in addition to Tresiba® and metformin for 26 weeks.

Study results include:

  • The addition of Victoza® once-dailyversus a single dose of NovoRapid® showed statistically significantly greater reduction of HbA1c (-0.73% versus -0.40%*) and body weight (-3.03 kg versus +0.72 kg[*])[3].
  • The observed rate of confirmed hypoglycaemic episodes (per patient year of exposure) was significantly lower when adding Victoza® once-dailycompared to a single dose of NovoRapid® (1.0 versus 8.15; estimated rate ratio: 0.13; 95% CI 0.08 to 0.21; p<0.0001)[3].

The three supportive studies included in the CHMP review were:

  • DUAL™ I, which compared the efficacy and safety of IDegLira (a combination of insulin degludec and liraglutide in one pen) versus Tresiba® or Victoza® alone in patients with type 2 diabetes, which was uncontrolled on metformin ± pioglitazone[4].
  • DUAL™ II, which compared the efficacy and safety of IDegLira versus Tresiba® alone in people with type 2 diabetes, which was  uncontrolled on basal insulin (20-40U) + metformin ± sulfonylurea or glinides[5].
  • LIRA-DETEMIR™, which compared a combination of the basal insulin Levemir® (insulin detemir) and Victoza® versus Victoza® alone in insulin-naïve patients with type 2 diabetes on metformin[6].

--------------------------------------------------

*. The numbers used for the label update were calculated using estimated means whereas the numbers used in the BEGIN™: VICTOZA® ADD ON trial publication were calculated using observed means.

 

About Tresiba® 

Tresiba® (insulin degludec) is the global brand name for insulin degludec, a basal insulin discovered and developed by Novo Nordisk. Once-daily Tresiba® provides a long duration of action beyond 42 hours, allowing for flexibility in day-to-day dosing time when needed with a minimum of eight hours and a maximum of 40 hours between injections, without compromising efficacy or risk of hypoglycaemia. Tresiba® has been studied in a large-scale clinical trial programme, BEGIN™, examining its impact on glucose control, hypoglycaemia and flexibility in day-to-day dosing time when needed.  Tresiba® has received regulatory approval in Argentina, Aruba, Bangladesh, Brazil, Chile, El Salvador, the EU, Iceland, India, Japan, Lebanon, Lichtenstein, Macedonia, Mexico, Norway, Russia and Switzerland.

About Victoza® 

Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia[†]. In addition, Victoza® reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered food intake.

Victoza® was launched in the EU in 2009 and is commercially available in more than 65 countries globally. Currently, there are more than 790,000 patients receiving Victoza® worldwide[7]. In the US, Victoza® was approved on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

[†] Hypoglycaemia has primarily been observed when Victoza® is combined with a sulfonylurea.

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 38,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit http://novonordisk.com.

______________

References:

  1. Tresiba® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2013.
  2. Victoza® Summary of Product Characteristics (SPC). Bagsværd, Denmark, Novo Nordisk A/S; 2009.
  3. Mathieu C, et al. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014 Jan 20 [epub ahead of print].
  4. DUAL™ I. Data on file NN9068-3697.
  5. DUAL™ II. Data on file  NN9068-3912.
  6. DeVries JH, et al. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012;35:1446-54.
  7. Internal Calculations based on IMS Midas Quantum data, July 2013.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discussed how businesses can gain an edge over competitors by empowering consumers to take control through IoT. He cited examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He also highlighted how IoT can revitalize and restore outdated business models, making them profitable ...
StackIQ has announced the release of Stacki 3.2. Stacki is an easy-to-use Linux server provisioning tool. Stacki 3.2 delivers new capabilities that simplify the automation and integration of site-specific requirements. StackIQ is the commercial entity behind this open source bare metal provisioning tool. Since the release of Stacki in June of 2015, the Stacki core team has been focused on making the Community Edition meet the needs of members of the community, adding features and value, while ...
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure. In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with b...
Big Data engines are powering a lot of service businesses right now. Data is collected from users from wearable technologies, web behaviors, purchase behavior as well as several arbitrary data points we’d never think of. The demand for faster and bigger engines to crunch and serve up the data to services is growing exponentially. You see a LOT of correlation between “Cloud” and “Big Data” but on Big Data and “Hybrid,” where hybrid hosting is the sanest approach to the Big Data Infrastructure pro...
In his session at @DevOpsSummit at 19th Cloud Expo, Yoseph Reuveni, Director of Software Engineering at Jet.com, will discuss Jet.com's journey into containerizing Microsoft-based technologies like C# and F# into Docker. He will talk about lessons learned and challenges faced, the Mono framework tryout and how they deployed everything into Azure cloud. Yoseph Reuveni is a technology leader with unique experience developing and running high throughput (over 1M tps) distributed systems with extre...
"We are a well-established player in the application life cycle management market and we also have a very strong version control product," stated Flint Brenton, CEO of CollabNet,, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
We all know the latest numbers: Gartner, Inc. forecasts that 6.4 billion connected things will be in use worldwide in 2016, up 30 percent from last year, and will reach 20.8 billion by 2020. We're rapidly approaching a data production of 40 zettabytes a day – more than we can every physically store, and exabytes and yottabytes are just around the corner. For many that’s a good sign, as data has been proven to equal money – IF it’s ingested, integrated, and analyzed fast enough. Without real-ti...
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., and Logan Best, Infrastructure & Network Engineer at Webair, focused on real world deployments of DDoS mitigation strategies in every layer of the network. He gave an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He also outlined what we have found in our experience managing and running thousands of Linux and Unix ...
"Operations is sort of the maturation of cloud utilization and the move to the cloud," explained Steve Anderson, Product Manager for BMC’s Cloud Lifecycle Management, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
A critical component of any IoT project is what to do with all the data being generated. This data needs to be captured, processed, structured, and stored in a way to facilitate different kinds of queries. Traditional data warehouse and analytical systems are mature technologies that can be used to handle certain kinds of queries, but they are not always well suited to many problems, particularly when there is a need for real-time insights.
UpGuard has become a member of the Center for Internet Security (CIS), and will continue to help businesses expand visibility into their cyber risk by providing hardening benchmarks to all customers. By incorporating these benchmarks, UpGuard's CSTAR solution builds on its lead in providing the most complete assessment of both internal and external cyber risk. CIS benchmarks are a widely accepted set of hardening guidelines that have been publicly available for years. Numerous solutions exist t...
Unless your company can spend a lot of money on new technology, re-engineering your environment and hiring a comprehensive cybersecurity team, you will most likely move to the cloud or seek external service partnerships. In his session at 18th Cloud Expo, Darren Guccione, CEO of Keeper Security, revealed what you need to know when it comes to encryption in the cloud.
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...