GliflOzin in eLderly Diabetic patiENts: A praGmatic intraclass Evaluation trial
Key facts
- Where
- Ancona, Bari, Bergamo, Catania, Conegliano, Foggia, Genoa, Latina, Milan, Monza, Naples, Novara, Orbassano, Padova, Palermo, Parma, Pavia, Pescara, Pisa, Rome, Siena, Treviso és Verona, OlaszországSee the 28 sites
- Phase
- 4. fázis
Where in Olaszország
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, OlaszországNo longer taking part
- University Of Bari Aldo MoroBari, OlaszországNo longer taking part
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, OlaszországNo longer taking part
- ARNAS Garibaldi Di CataniaCatania, OlaszországNo longer taking part
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca TrevigianaConegliano, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, OlaszországNo longer taking part
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországNo longer taking part
- Ospedale Santa Maria Goretti LatinaLatina, OlaszországNo longer taking part
- ASST Fatebenefratelli SaccoMilan, OlaszországNo longer taking part
- ASST Grande Ospedale Metropolitano NiguardaMilan, OlaszországNo longer taking part
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, OlaszországNo longer taking part
- Policlinico Di Monza S.p.A.Monza, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, OlaszországNo longer taking part
- Azienda Ospedaliera di PadovaPadova, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria ParmaParma, OlaszországNo longer taking part
- Fondazione IRCCS Policlinico San MatteoPavia, OlaszországNo longer taking part
- Azienda Sanitaria Locale di PescaraPescara, OlaszországNo longer taking part
- Azienda Ospedaliero Universitaria PisanaPisa, OlaszországNo longer taking part
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, OlaszországNo longer taking part
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria SeneseSiena, OlaszországNo longer taking part
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca TrevigianaTreviso, OlaszországNo longer taking part
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Center For Outcomes Research And Clinical Epidemiology S.r.l.
- Trial code
- EU 2024-518915-20-00
- Record updated
- 2025. szeptember 30.
- Original description
The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-3 hypoglycaemia at the end of the study at 24 months0Read full original descriptionShow less
Intraclass safety and efficacy comparison among SGLT-2 inhibitors in elderly patients with type 2 diabetes. A pragmatic, phase IV, multicenter, open-label, randomised controlled trial.
The primary objective is to compare the proportion of patients treated with each SGLT2i drug, who achieve the individualized HbA1c target without level-3 hypoglycaemia at the end of the study at 24 months0
Inclusion: Type 2 diabetes; Age >=70 years; Men or women; Established cardiovascular disease (symptomatic or asymptomatic) or eGFR <90 ml / min / 1.73 m2 but above the threshold for starting therapy with all SGLTe inhibitors; HbA1c higher than the individualized target value; Clinical indication when starting a therapy with SGLT2i; Ability to give written informed consent.
Exclusion: Participation in another interventional drug trial; Intolerance to lactose and any other contraindication to the study drugs; Very high risk of urinary infections (more than 2 episodes in the last 6 months); Age> 90 years; Estimated life expectancy <1 year; Recent unintentional weight loss (> 5% in <6 months); Inability to give written informed consent.