BAGSVĆRD, Denmark, December 2, 2016 /PRNewswire/ --
This material is intended for global medical media only. For journalistic assessment and preparation before publication.
Novo Nordisk today announced new phase 3b trial (DUAL VII) results with Xultophy® (IDegLira). Xultophy® is a once-daily, single injection fixed combination of a long-acting basal insulin (insulin degludec) and a glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide).[1] The open-label trial investigated the efficacy and safety of Xultophy® compared with insulin glargine U100 in combination with insulin aspart at all main meals, after 26 weeks of treatment in 506 adults with type 2 diabetes.[2],[3]
The trial successfully achieved its objective by demonstrating that treatment with Xultophy® is non-inferior to insulin glargine U100 in combination with insulin aspart with regards to lowering of HbA1c. From a mean baseline HbA1c of 8.2%, both patient groups reached a similar HbA1c level of 6.7% after 26 weeks of treatment. At the end of the trial, people treated with Xultophy® required 40.1 units compared to a total of 84.6 units of insulin for people treated with insulin glargine U100 in combination with insulin aspart.[3]
People treated with Xultophy® showed a superior reduction of 89% in the rate of severe or blood glucose confirmed symptomatic hypoglycaemic episodes compared to insulin glargine U100 in combination with insulin aspart. Furthermore, from a mean baseline body weight of 87.7 kg, people treated with Xultophy® experienced weight loss of 0.9 kg compared with weight gain of 2.6 kg for people treated with the basal-bolus regimen; a superior weight difference of -3.6 kg.[3]
"We are excited about the results of DUAL VII, showing the important benefits Xultophy® offers for people inadequately controlled on insulin glargine U100 as an alternative to intensification with basal-bolus therapy" said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk A/S. "Xultophy® shows these impressive results, including reduction in hypoglycaemia and body weight, with a much lower dose compared to insulin glargine U100 in combination with insulin aspart at the end of the study."
The safety profile of Xultophy® in DUAL VII was generally consistent with previous Xultophy® clinical trials.[3]
The complete trial results will be presented in the first half of 2017.
About Xultophy®
Xultophy® is a once-daily single injection fixed combination of long-acting insulin degludec (Tresiba®) and the GLP-1 receptor agonist liraglutide (Victoza®). The maximum dose of Xultophy® is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide).[1] Xultophy® has been investigated in seven trials in the DUAL clinical trial programme, encompassing more than 4,000 people with type 2 diabetes. Phase 3b trials are still ongoing. On 21 November 2016, Xultophy® was approved by the FDA under the brand name Xultophy® 100/3.6.[4] On 18 September 2014, Xultophy® was granted marketing authorisation by the European Commission and approved in Switzerland on 12 September 2014.[1],[5]
About DUAL VII
DUAL VII was a phase 3b, 26-week, randomised, open-label, multicentre trial conducted in 12 countries with 506 patients.[2],[3] The trial was designed to investigate the safety and efficacy of Xultophy® vs basal-bolus therapy in adults with type 2 diabetes previously treated with insulin glargine U100 and metformin.[2]
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information Media: Katrine Sperling +45-4442-6718 [email protected]
Michael Bachner (US) +1-609-786-7796 [email protected]
Investors: Peter Hugreffe Ankersen +45-3075-9085 [email protected]
Melanie Raouzeos +45-3075-3479 [email protected]
Hanna Ögren +45-3075-8519 [email protected]
Anders Mikkelsen +45-3079-4461 [email protected]
Kasper Veje (US) +1-609-235-8567 [email protected]
References
1. EMA. Xultophy® summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf Last accessed: November 2016.
2. ClinicalTrials.gov. A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus. Available at: https://clinicaltrials.gov/ct2/show/NCT02420262?term=ideglira%2C+basal-bolus&rank=1 Last accessed November 2016.
3. Novo Nordisk, Data on file.
4. Novo Nordisk. Novo Nordisk receives US FDA approval for Xultophy® 100/3.6. Available at: http://www.novonordisk.com/bin/getPDF.2058006.pdf Last accessed November 2016.
5. SwissMedic. Xultophy®: information for professionals. 2014.
Advertisement
This material is intended for global medical media only. For journalistic assessment and preparation before publication.
Novo Nordisk today announced new phase 3b trial (DUAL VII) results with Xultophy® (IDegLira). Xultophy® is a once-daily, single injection fixed combination of a long-acting basal insulin (insulin degludec) and a glucagon-like peptide-1 (GLP-1) receptor agonist (liraglutide).[1] The open-label trial investigated the efficacy and safety of Xultophy® compared with insulin glargine U100 in combination with insulin aspart at all main meals, after 26 weeks of treatment in 506 adults with type 2 diabetes.[2],[3]
Advertisement
The trial successfully achieved its objective by demonstrating that treatment with Xultophy® is non-inferior to insulin glargine U100 in combination with insulin aspart with regards to lowering of HbA1c. From a mean baseline HbA1c of 8.2%, both patient groups reached a similar HbA1c level of 6.7% after 26 weeks of treatment. At the end of the trial, people treated with Xultophy® required 40.1 units compared to a total of 84.6 units of insulin for people treated with insulin glargine U100 in combination with insulin aspart.[3]
People treated with Xultophy® showed a superior reduction of 89% in the rate of severe or blood glucose confirmed symptomatic hypoglycaemic episodes compared to insulin glargine U100 in combination with insulin aspart. Furthermore, from a mean baseline body weight of 87.7 kg, people treated with Xultophy® experienced weight loss of 0.9 kg compared with weight gain of 2.6 kg for people treated with the basal-bolus regimen; a superior weight difference of -3.6 kg.[3]
"We are excited about the results of DUAL VII, showing the important benefits Xultophy® offers for people inadequately controlled on insulin glargine U100 as an alternative to intensification with basal-bolus therapy" said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk A/S. "Xultophy® shows these impressive results, including reduction in hypoglycaemia and body weight, with a much lower dose compared to insulin glargine U100 in combination with insulin aspart at the end of the study."
The safety profile of Xultophy® in DUAL VII was generally consistent with previous Xultophy® clinical trials.[3]
The complete trial results will be presented in the first half of 2017.
About Xultophy®
Xultophy® is a once-daily single injection fixed combination of long-acting insulin degludec (Tresiba®) and the GLP-1 receptor agonist liraglutide (Victoza®). The maximum dose of Xultophy® is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide).[1] Xultophy® has been investigated in seven trials in the DUAL clinical trial programme, encompassing more than 4,000 people with type 2 diabetes. Phase 3b trials are still ongoing. On 21 November 2016, Xultophy® was approved by the FDA under the brand name Xultophy® 100/3.6.[4] On 18 September 2014, Xultophy® was granted marketing authorisation by the European Commission and approved in Switzerland on 12 September 2014.[1],[5]
About DUAL VII
DUAL VII was a phase 3b, 26-week, randomised, open-label, multicentre trial conducted in 12 countries with 506 patients.[2],[3] The trial was designed to investigate the safety and efficacy of Xultophy® vs basal-bolus therapy in adults with type 2 diabetes previously treated with insulin glargine U100 and metformin.[2]
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information Media: Katrine Sperling +45-4442-6718 [email protected]
Michael Bachner (US) +1-609-786-7796 [email protected]
Investors: Peter Hugreffe Ankersen +45-3075-9085 [email protected]
Melanie Raouzeos +45-3075-3479 [email protected]
Hanna Ögren +45-3075-8519 [email protected]
Anders Mikkelsen +45-3079-4461 [email protected]
Kasper Veje (US) +1-609-235-8567 [email protected]
References
1. EMA. Xultophy® summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf Last accessed: November 2016.
2. ClinicalTrials.gov. A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus. Available at: https://clinicaltrials.gov/ct2/show/NCT02420262?term=ideglira%2C+basal-bolus&rank=1 Last accessed November 2016.
3. Novo Nordisk, Data on file.
4. Novo Nordisk. Novo Nordisk receives US FDA approval for Xultophy® 100/3.6. Available at: http://www.novonordisk.com/bin/getPDF.2058006.pdf Last accessed November 2016.
5. SwissMedic. Xultophy®: information for professionals. 2014.
