Status: Finalised First registered on: 13/11/2015
Last updated on: 14/02/2019
1. Study identification
EU PAS Register NumberEUPAS10902
Official titlePattern of use of incretin-based drugs in clinical practice
Study title acronym
Study typeObservational study
Brief description of the studyIncretin 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsARS
Department/Research groupOsservatorio di Epidemiologia
Organisation/affiliationAgenzia regionale di sanità della Toscana (ARS)
Website/Homepagehttp://www.ars.toscana.it/it/
Details of (Primary) lead investigator
Title Dr
Last name Giuseppe
First name Roberto
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

University of Messina
National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/09/2015
Start date of data collection09/11/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report31/01/201731/01/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherThis is an independent study based on a spontaneous initiative of the participanting partners100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Roberto
First name Giuseppe
Address line 1via Pietro Dazzi 1
Address line 2 
Address line 3 
CityFlorence 
Postcode 
CountryItaly
Phone number (incl. country code)393281831024 
Alternative phone number 
Fax number (incl. country code) 
Email address giuseppe.roberto@ars.toscana.it
Public Enquiries
Title Dr 
Last name Giuseppe 
First name Roberto 
Address line 1Via Pietro Dazzi 1 
Address line 250141 
Address line 3 
CityFlorence 
Postcode50141 
CountryItaly 
Phone number (incl. country code)39-3281831024 
Alternative phone number 
Fax number (incl. country code) 
Email address giuseppe.roberto@ars.toscana.it 
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