Clinical outcomes of novel antidiabetic medicines: Real-world evidence from Slovenian population-based study (CONAMS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43742
• EU PAS number:
  EUPAS32558
• Study ID:
  43742
• Official title and acronym:
  Clinical outcomes of novel antidiabetic medicines: Real-world evidence from Slovenian population-based study (CONAMS)
• DARWIN EU® study:
  No
• Study countries:
  Slovenia
• Study description:
  Two studies will be performed using real-world data from administrative claims databases in Slovenia. First retrospective cohort study will evaluate the risk of cardiovascular events in patients with type 2 diabetes using different classes of antidiabetic medicines. Second retrospective cohort study will examine the risk of amputations in patients with type 2 diabetes treated with SGLT-2 inhibitors compared to those treated with DPP-4 inhibitors.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Social Pharmacy, Faculty of pharmacy, University of Ljubljana

Slovenia

Study timelines

Date when funding contract was signed

Actual: 01/10/2017

Study start date

Actual: 30/07/2019

Data analysis start date

Planned: 13/01/2020

Actual: 01/07/2020

Date of final study report

Planned: 30/06/2020

Actual: 30/09/2021

Sources of funding

Other

More details on funding

Young researchers' training programme funded by Slovenian Research Agency (Programme Group No. P1-0189).

Regulatory

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