Alogliptin-5002: Association between therapy with Dipeptidyl peptidase-4 (DPP-4) inhibitors and risk of ileus: A cohort study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44018
• EU PAS number:
  EUPAS8734
• Study ID:
  44018
• Official title and acronym:
  Alogliptin-5002: Association between therapy with Dipeptidyl peptidase-4 (DPP-4) inhibitors and risk of ileus: A cohort study
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Ileus is a form of non-mechanical bowel obstruction. A recent literature report of three cases of ileus in DPP-4 inhibitors treated patients in Japan has triggered this epidemiology study to quantify and assess the risk. To quantify the incidence rate of ileus among T2DM patients new users of alogliptin, other DPP-4 inhibitors, Glucagon-Like Polypeptide-1 (GLP-1) receptor agonists and Voglibose. This is a retrospective cohort study using a Japanese Medical Data Vision (MDV) claims database. The study population includes T2DM patients who were new users of alogliptin, other DPP-4 inhibitors, GLP-1 receptor agonists, or Voglibose between 04/01/2010-04/30/2014. New users defined as patients without any previous prescriptions for medications of interest before cohort entry. Patients were aged 40+ years at cohort entry and were followed up until the earliest of: incident diagnosis of ileus, or the earliest of the last prescription date of the first therapy episode or day before date of treatment switch/add-on. Incidence rates of ileus were assessed, both overall and by risk time window. Poisson regression models assessed incidence rate ratios (IRR) for ileus with 95% confidence intervals (95% CI).
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned: 11/12/2014

Actual: 23/12/2014

Study start date

Planned: 30/01/2015

Actual: 30/01/2015

Data analysis start date

Planned: 01/02/2015

Actual: 01/02/2015

Date of final study report

Planned: 31/07/2015

Actual: 09/07/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable