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XULTOPHY (insulin degludec/liraglutide), antidiabetic

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.

Actual benefit



Improvement in actual benefit

V (absence)


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