Simplified follow-up clinical trial in type 2 diabetes ESSIDIA - Pilot

Irene Supper, Catherine Cornu, Remy Boussageon, Sylvie Erpeldinger, Olivier Saint Lary, Sabine Bayen

Keywords: type 2 diabetes; clinical trial; general practice; network

Important discrepancies between guidelines exist regarding first line treatment of type 2 diabetes (T2D).
The 2019 European recommendations propose first-line monotherapy with a SGLT2-i (sodium-glucose-2 co-transporter inhibitors) or a GLP1-a (glucose-like peptide 1agonist) in case of high cardiovascular risk, while the northern american 2020 recommendations maintain metformin as 1st line monotherapy; a SGLT2-i or a GLP1-a can be added depending on the cardiovascular risk. Metformin is inexpensive and has a favorable risk profile, but according to a meta-analysis published by the Cochrane Collaboration (Madsen 2020), there is no strong evidence that metformin protects against cardiovascular events.

Research questions:
To directly compare the benefit / risk ratio of SGLT2 inhibitor , GLP-1 agonists and metformin, in patients with T2D in primary care.

This protocol for a randomized clinical trial will use authorized treatments in T2D in general practice with simplified follow-up using the French medico-administrative data base. Patients will be recruited, informed, their written consent collected, and they will be randomized by GPs in three groups: i) metformin; ii) GLP1-a and iii) SGLT2-i and followed-up for 5 years.
About 30,000 patients need to be included by 6000 GPs, to compare the incidence of major cardiovascular events, deaths, and non cardiovascular major events between groups.
Simple and adapted procedures will be put in place in collaboration with GPs, to ensure the feasibility of recruitment and follow-up.

Expected results are to produce data for evidence-based guidelines.
The challenge is to obtain the adhesion of GPs, and to find organisations to allow GPs to perform research in their daily practice.
Another challenge is to raise funds for such a trial. A pilot phase trial protocol will be submitted to an academic call, simultaneously in several regions in France, for the first time in France.

This research question concerns more than 462 million individuals worldwide.

Points for discussion:
Challenge of performing clinical trials in general practice.

How is it possible to develop primary care networks in France