NCT03918148Completed
Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)
Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 19 Apr 2024
Brief summary (registry, in English)
GIOIA represents a multicenter pragmatic prospective cohort study, aimed at evaluating the effects of SGLT2 inhibitors currently marketed (dapagliflozin, canagliflozin, empagliflozin) on markers of vascular, myocardial and renal damage, in patients with type 2 diabetes not well controlled with metformin and/or basal insulin. The changes of the interest outcomes are compared with those obtained with a comparator glucose lowering class (DPP-4inhibitors) over a follow-up of two years.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1150 (actual)
- First submitted
- 9 Apr 2019
- Start date
- 15 Jan 2018
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Diseases
- Type 2 diabetes
- NCT number
- NCT03918148
What you commit to
- Study type: Observational
- Participants enrolled: 1150
- From 15 Jan 2018 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous therapy with SGLT-2i or DPP4-i in the 3 months prior to the study enrollment
Other illness
- Type 1 diabetes or secondary diabetes resulting from specific causes
- History of neurovascular ulcers
- History of cancer within the last 5 years
Lab values
- Serum creatinine level ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
- eGFR ≤ 60 ml/min/1.73 m2
Other
- Pregnancy or active breast-feeding
Who the study is looking for
- type 2 diabetes for at least 5 years
- new use of an SGLT2-I or DPP4-I as add-on to metformin or insulin according to clinical practice
- HbA1c levels ≥ 7% and ≤ 8.5%
- eGFR ≥ 60 ml/min/1.73 m2
Age in the registry: 35 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unit of Diabetes Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.