Novo Nordisk completes fourth phase 3a trial with semaglutide

Novo Nordisk announced the headline results from the fourth phase 3a trial for semaglutide, SUSTAIN2. Semaglutide is a new GLP-1 analogue administered subcutaneously once weekly. The double-blinded trial investigated the efficacy and safety of 0.5 mg and 1.0 mg semaglutide compared with 100 mg sitagliptin, a once-daily DPP-IV inhibitor, after 56 weeks of treatment in 1,231 people with type 2 diabetes, where both drugs were added on to metformin, thiazolidinedione (TZD) or a combination of metformin/TZD. 

The trial successfully achieved its objective by demonstrating that from a mean baseline HbA1c of 8.1%, people treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.3% and 1.6% respectively, compared to an improvement in HbA1cof 0.5% with 100 mg sitagliptin.

69% of the people treated with 0.5 mg semaglutide and 78% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) treatment target of HbA1c below 7% compared with 36% of the people treated with 100 mg sitagliptin.

Furthermore, from a mean baseline body weight of 89 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 4.3 kg and 6.1 kg respectively, compared with a weight loss of 1.9 kg for people treated with 100 mg sitagliptin.

In the trial, semaglutide appeared to have a safe and well-tolerated profile. The most common adverse event was nausea which diminished over time. Nausea was reported by 18% of the people treated with 0.5 mg semaglutide and by 18% of the people treated with 1.0 mg semaglutide, compared with 7% of people treated with 100 mg sitagliptin. The discontinuation rate due to adverse events was 8% and 10% for people treated with 0.5 mg semaglutide and 1.0 mg semaglutide respectively, compared to 3% for people treated with 100 mg sitagliptin.

Novo Nordisk files for regulatory approval of faster-acting insulin

Novo Nordisk announced the submission to the European Medicines Agency of the Marketing Authorisation Application (MAA) for the approval of faster-acting insulin aspart. Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes.

 

Novo Nordisk expects to file the new drug application for faster-acting insulin aspart to the US Food and Drug Administration before year-end 2015.  

The filing of faster-acting insulin aspart is based on the results from the 'onset' clinical trial programme which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial control versus NovoRapid^® and an HbA_1c reduction on par with NovoRapid^®. For people with type 1 diabetes, faster-acting insulin aspart results from the double-blinded onset 1 trial showed statistically significantly greater HbA_1c reduction when dosed at mealtime or similar HbA_1c reduction when dosed 20 minutes after a meal compared to NovoRapid^®. Across the onset trials, faster-acting insulin aspart had a safe and well tolerated profile, with the most common adverse event being hypoglycaemia, similar to the levels observed with NovoRapid^®. 

Victoza provides greater glycaemic control

New findings from a network meta-analysis show that treatment with Victoza® (liraglutide) provides a greater HbA1c reduction and an improved likelihood of reaching glycaemic goals compared to sodium-glucose co-transporter 2 (SGLT-2) inhibitors in people with type 2 diabetes who are inadequately controlled with metformin alone or in combination with sulfonylurea, dipeptidyl peptidase-4 (DPP-4) inhibitors or thiazolidinedione. Findings were presented at the World Diabetes Congress of the International Diabetes Federation (IDF) in Vancouver, Canada.

For details contact:

Katrine Sperling	+45 4442 6718	krsp@novonordisk.com
Åsa Josefsson	+45 3079 7708	aajf@novonordisk.com

US FDA approves Tresiba and Ryzodeg

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Tresiba^® and Ryzodeg^® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs). 

Tresiba^®, the approved brand name for insulin degludec, is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours. In 'treat-to-target' studies comparing Tresiba^® to insulin glargine, people using Tresiba^® achieved similar reduction in long-term blood glucose (HbA_1c), numerically greater fasting plasma glucose reduction, while using numerically lower doses of insulin in a majority of the studies. Furthermore, the studies demonstrated that Tresiba^® is the first basal insulin to offer people with diabetes the possibility of injecting their basal insulin at any time of the day with the option to adjust the time of injection. 

Ryzodeg^® 70/30, the approved brand name for insulin degludec/insulin aspart, contains insulin degludec in a soluble co-formulation with insulin aspart. Ryzodeg^® 70/30 can be administered once or twice daily with any main meal. In a 'treat-to-target' study supporting the new drug application where Ryzodeg^® 70/30 was compared to NovoLog^® Mix 70/30, Ryzodeg^® 70/30 showed equivalent reductions in HbA_1c.

Lilly and Sanofi Reach Settlement Agreement

Eli Lilly and Company has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar®. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the U.S. on December 15, 2016. 

 Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar in the Kwikpen® device globally. Further details regarding the settlement are confidential. The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.