Trials / Completed
CompletedNCT03918148
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,150 (actual)
- Sponsor
- University of Campania Luigi Vanvitelli · Academic / Other
- Sex
- All
- Age
- 35 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SGLT-2i | Dapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin |
| DRUG | DPP-4i | Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin |
Timeline
- Start date
- 2018-01-15
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2019-04-17
- Last updated
- 2024-04-19
Locations
1 site across 1 country: Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03918148. Inclusion in this directory is not an endorsement.