BAGSVAERD, Denmark I December 2, 2016 I 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
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 recieves 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.
SOURCE: Novo Nordisk
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BAGSVAERD, Denmark I December 2, 2016 I 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
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 recieves 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.
SOURCE: Novo Nordisk
Post Views: 286
