Pattern of use of incretin-based drugs in clinical practice

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28087
• EU PAS number:
  EUPAS10902
• Study ID:
  28087
• Official title and acronym:
  Pattern of use of incretin-based drugs in clinical practice
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Incretin based drugs represent a class of hypoglicemic agents including different molecules approved during the last decade for the treatment of type 2 diabetes (T2DM). The clinical efficacy of this class of drugs in the treatment of T2DM relies on the potentiaton of the activity of the glucagon-like peptide 1 (GLP-1), an endogenous hormon belonging to the family of incretins that exerts an important role in the glycemic omeostasis. In particular, on the basis of the mechanism of action, incretin-based drugs can be distinguished in two groups: glucagon like peptide-1 analogues and dipeptidilpeptidase-4 inhibitors (DPP4i). Different randomized clinical trials demonstrated a positive risk/benefit profile for these hypoglicemic agents. However, given the relatively recent commercialization, evidence on the pattern of use of these medications in clinical practice is still scarce. Different incretin based medicines are currently available in Italy. Although a trend of increase of their use has been reported in literature, specific information concerning GLP-1 analogues and DPP-4i or the individual molecules belonging to the two groups are still lacking. Moreover, since the effectiveness and safety profile of these drugs cannot be considered completely established yet, evidence on the exposure of the general population to these medications, as well as the characterization of treated patients, becomes of paramount importance for planning large scale observational pharmacoepidemiological studies. Therefore, the aim of this study is to describe in greater details the pattern of use of incretin-based drugs in a large sample of the Italian general population. For this purpose, electronic health records from three population-based administrative data bases collecting information on almost 6 million inhabitants from 2 Italian regions, Tuscany and Umbria, and one Local Health Authority, Caserta, will be analyzed.
• Study status:
  Finalised

Research institution and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina

Italy

National Centre for Epidemiology, Italian National Institute of Health Rome, Italy

Contact details

Giuseppe Roberto

Study contact

[e-mail]

Roberto Giuseppe

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual: 07/09/2015

Data collection

Actual: 09/11/2015

Date of final study report

Planned: 31/01/2017

Actual: 31/01/2017

Sources of funding

Other

More details on funding

This is an independent study based on a spontaneous initiative of the participanting partners

Study protocol

Initial protocol

Pattern of use of incretin based drugs in clinical practice

Updated protocol

Pattern of use of incretin based drugs in clinical practice_version_1.1

Regulatory

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