WC500169468

Procedure scope: Update of SmPC sections 4.4 and 4.8 to reflect results of study 305, a phase 3,
randomized, double-blind, active-controlled, 2-year study, designed to assess the efficacy and safety
of alogliptin in combination with metformin compared with glipizide in combination with metformin in
adults with type 2 diabetes mellitus
MAH(s): Takeda Pharma A/S
Background
Incresync is a centrally authorised medicine containing the combination of alogliptin and pioglitazone
used as a second- or third-line treatment in adult patients aged 18 years and older with type-2
diabetes mellitus in selected patients.
The CHMP is evaluating a type II variation procedure for Incresync, to reflect results of study 305, a
phase 3, randomized, double-blind, active-controlled, 2-year study, designed to assess the efficacy and
safety of alogliptin in combination with metformin compared with glipizide in combination with
metformin in adults with type 2 diabetes mellitus. The PRAC is responsible for providing advice to the
CHMP on the necessary updates to the RMP to support this variation.
Summary of advice
The RMP version 6 for Incresync (alogliptin, pioglitazone) in the context of the variation under
evaluation by the CHMP was considered acceptable provided some sections are amended
before finalisation of the variation procedure by the CHMP.
No new safety concerns were identified with the studies. Therefore areas of missing
information should then be updated and the studies should be removed from the RMP.
The safety concerns in the RMP for alogliptin-containing products should be reflected
consistently. The MAH should include “Patients requiring renal or peritoneal dialysis”, should
re-include “Patients with severe hepatic impairment”, and add “Patients with severe heart
failure (NYHA class IV)” among the safety concerns.
5.2.3. Alogliptin – VIPIDIA (CAP)
alogliptin, metformin - VIPDOMET (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Menno van der Elst (NL)
Administrative details:
Procedure number(s): EMEA/H/C/002182/WS0520/0002, EMEA/H/C/002654/WS0520/0001
Procedure scope: Update of SmPC sections 4.4, 4.8, and 5.1 to reflect results of study 305, a phase 3,
randomized, double-blind, active-controlled, 2-year study, designed to assess the efficacy and safety
of alogliptin in combination with metformin compared with glipizide in combination with metformin in
adults with type 2 diabetes mellitus
MAH(s): Takeda Pharma A/S
Background
Vipidia is a centrally authorised medicine containing alogliptin, a dipeptidyl peptidase 4 (DPP-
4)inhibitor, indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve
glycaemic control in combination with other glucose lowering medicinal products including insulin,
when these, together with diet and exercise, do not provide adequate glycaemic control.
Vipidomet is a combination product containing alogliptin and metformin indicated as an adjunct to diet
and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 29/73