XULTOPHY (insulin degludec/liraglutide), antidiabetic
DIABETOLOGY - Update
Opinions on drugs - Posted on Mar 29 2018
Reason for request
Amendments to the conditions of inclusion
Substantial clinical benefit in patients with type 2 diabetes but no clinical added value demonstrated in case of failure of glycaemic control with the combination of metformin/basal insulin
- XULTOPHY has Marketing Authorisation in the treatment of adults with type 2 diabetes to improve glycaemic control in combination with oral antidiabetics when these, alone or combined with a basal insulin, do not provide adequate glycaemic control.
- An open-label study (which limits the scope of its results) demonstrated the non-inferiority of XULTOPHY compared with a basal-bolus insulin regimen on variation in HbA1c at 26 weeks in patients who were not controlled by dual therapy with insulin glargine and metformin.
- The main characteristics of the safety profile of XULTOPHY are gastrointestinal disorders, including nausea.
- It is not suitable for patients with type 2 diabetes who require an insulin dose exceeding 50 units.
Improvement in actual benefit
Évaluation des médicaments