VIPIDIA (alogliptin) and VIPDOMET (alogliptin/metformin), antidiabetics

DIABETOLOGY - New medicinal product
Opinions on drugs - Posted on Feb 23 2015

Reason for request

Inclusion

No clinical benefit demonstrated in the management of patients with type 2 diabetes

 

  • VIPIDIA has Marketing Authorisation in the treatment of type 2 diabetes in combination with other blood glucose-lowering medicines, including insulin, when these, combined with diet and exercise, do not provide adequate glycaemic control.
  • Its efficacy has been demonstrated in patients inadequately controlled in dual therapy with metformin or a sulfonylurea and in triple therapy with insulin and metformin.
  • VIPDOMET has Marketing Authorisation in the treatment of type 2 diabetes:

- in adult patients inadequately controlled by the maximum tolerated dose of metformin in monotherapy, or in those already receiving an alogliptin-metformin combination.

- in combination with pioglitazone in adult patients inadequately controlled by the maximum tolerated dose of metformin and pioglitazone.

- in combination with insulin in patients for whom a stable dose of insulin and metformin alone is not sufficient to provide adequate glycaemic control.

  • The fixed-dose combination of alogliptin/metformin has not shown any clinical added value compared with the free combination of alogliptin and metformin.

Clinical Benefit

Substantial

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Moderate

Clinical Added Value

no clinical added value

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