Status: Planned First registered on: 01/08/2017
Last updated on: 14/02/2019
1. Study identification
EU PAS Register NumberEUPAS20169
Official titleTime to treatment intensification in patients receiving metformin+incretin-based medicines versus metformin+other hypoglicemics
Study title acronymTime to treatment intensification with incretins
Study typeObservational study
Brief description of the studyDue to the progressive nature of tipe 2 diabetes, antidiabetic drugs tend to lose their efficacy over time so that treatment intensification is required. Current guidelines recommend metformin as the first choice in newly treated patients with type 2 diabetes. Among possible second-line add-on treatments, incretin-based medicines have been associated to a more durable glycemic control, although available evidence from observational studies is conflicting. The aim of this study is to the analyse routinely collected Italian admistrative data collected from different local and regional health authorities in order to compare the time to treatment intensification in patients with type 2 diabetes receiving incretin-based medicines versus other non-insulin antidiabetics as add-on therapy to metformin.
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?5

University of Messina
UPO
UNIBO
ARS
Pharmacoepidemiology Unit - ISS
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 signed16/01/2017
Start date of data collection15/09/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report31/08/2019
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 was a spontaneous initiative of the researchers participating to the project. No fubndings were received from any external source.100
5. Contact details for enquiries
Scientific 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)39-0554624320 
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)39-0554624320 
Alternative phone number 
Fax number (incl. country code) 
Email address giuseppe.roberto@ars.toscana.it 
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