Status: Finalised First registered on: 17/06/2014
Last updated on: 08/07/2014
1. Study identification
EU PAS Register NumberEUPAS6779
Official titleComparative effectiveness of insulines vs analogues to prevent complications of diabetes
Study title acronymCER insulin vs analogues
Study typeObservational study
Brief description of the studyThe major challenge concerning the treatment of diabetes is representended by the prevention of vascular and metabolic diabetic complications and the related consequences for the health status of patients. Human insulin and/or its analogues are used to treat both type 1 diabetes mellitus, from its first onset, and type 2 diabetes, in its advanced phase. For both types of insulin, different formulations with different time to onset and duration of action, are currently available in order to provide patients with the most appropriate therapeutic option to mantain blood glucose concenration within the phisiological range throughout the day. In fact, different long-term follow-up studies of randomized clinical trials have found an association between inadequate plasma glucose control and the occurrence of diabetes complications. Insulin analogues possess benefit relative to human insulins in terms of glycemic control however, little is known about the long-term comparative effectiveness of insulin analogue with respect to human insulins in reducing the risk of cardiovascular and metabolic complications of diabetes. The main objective of this study was to assess the risk of diabetes complications in patients treated with insulin analogues against those using human insulin in a clinical pratice setting (i.e. Tuscany region). The secondary scope of this study was to evaluate healthcare costs respectively associated with the use of human insulins and insulin analogues (e.g. pharmacological treatment related to diabetes, hospitalizations, diagnostic procedures).
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 Gini
First name Rosa
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

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 signed09/09/201309/09/2013
Start date of data collection30/09/201318/11/2013
Start date of data analysis
Date of interim report, if expected
Date of final study report02/04/201409/06/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly Italia50
Charities
Government bodyARS50
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Gini
First name Rosa
Address line 1Via Pietro Dazzi 1
Address line 250141 
Address line 3 
CityFlorence 
Postcode50141 
CountryItaly
Phone number (incl. country code)39-0554624341 
Alternative phone number 
Fax number (incl. country code) 
Email address rosa.gini@ars.toscana.it
Public Enquiries
Title Dr 
Last name Gini 
First name Rosa 
Address line 1Via Pietro Dazzi 1 
Address line 250141 
Address line 3 
CityFlorence 
Postcode50141 
CountryItaly 
Phone number (incl. country code)39-0554624341 
Alternative phone number 
Fax number (incl. country code) 
Email address rosa.gini@ars.toscana.it 
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