2024-518915-20-00CompletedPhase 4
GliflOzin in eLderly Diabetic patiENts: A praGmatic intraclass Evaluation trial
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Sept 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1167 (actual)
- First submitted
- 15 Oct 2024
- Start date
- 16 Feb 2022
- Lead sponsor
- Center For Outcomes Research And Clinical Epidemiology S.r.l.
- Diseases
- Type 2 diabetes
- EU CT number
- 2024-518915-20-00
- EudraCT number
- 2021-001167-24
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 1167
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another interventional drug trial
- Intolerance to lactose and any other contraindication to the study drugs
Other illness
- Very high risk of urinary infections (more than 2 episodes in the last 6 months)
Age
- Age> 90 years
Other
- Estimated life expectancy <1 year
- Recent unintentional weight loss (> 5% in <6 months)
- Inability to give written informed consent
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi | Ancona | Italy | Completed |
| University Of Bari Aldo Moro | Bari | Italy | Completed |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | Italy | Completed |
| ARNAS Garibaldi Di Catania | Catania | Italy | Completed |
| Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana | Conegliano | Italy | Completed |
| Azienda Ospedaliero Universitaria Ospedali Riuniti | Foggia | Italy | Completed |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Completed |
| Ospedale Santa Maria Goretti Latina | Latina | Italy | Completed |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
| ASST Fatebenefratelli Sacco | Milan | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Completed |
| Policlinico Di Monza S.p.A. | Monza | Italy | Completed |
| Azienda Ospedaliera Universitaria Federico II Di Napoli | Naples | Italy | Completed |
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | Completed |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Italy | Completed |
| Azienda Ospedaliera di Padova | Padova | Italy | Completed |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Italy | Completed |
| Azienda Ospedaliero Universitaria Parma | Parma | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Completed |
| Azienda Sanitaria Locale di Pescara | Pescara | Italy | Completed |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Completed |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Completed |
| Azienda Ospedaliera Universitaria Senese | Siena | Italy | Completed |
| Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana | Treviso | Italy | Completed |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.