Time to treatment intensification in patients receiving metformin+incretin-based medicines versus metformin+other hypoglicemics (Time to treatment intensification with incretins)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28096
• EU PAS number:
  EUPAS20169
• Study ID:
  28096
• Official title and acronym:
  Time to treatment intensification in patients receiving metformin+incretin-based medicines versus metformin+other hypoglicemics (Time to treatment intensification with incretins)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Due 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.
• Study status:
  Planned

Research institution and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Unit of Medical Statistics and Cancer Epidemiology, University of Eastern Piedmont (UPO)

Italy

Pharmacoepidemiology Unit - National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità (ISS)

Italy

Department of Pharmacology, University of Bologna (UNIBO)

Italy

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

Italy

Contact details

Roberto Giuseppe

Study contact

[e-mail]

Roberto Giuseppe

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual: 16/01/2017

Data collection

Planned: 15/09/2017

Date of final study report

Planned: 31/08/2019

Sources of funding

Other

More details on funding

This was a spontaneous initiative of the researchers participating to the project. No fubndings were received from any external source.

Study protocol

Initial protocol

Time to treatment intensification_incretins vs other hypoglicemics_Protocol_v1.1

Updated protocol

Time to treatment intensification_incretins vs other hypoglicemics_Protocol_v1.2

Regulatory

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