Clinical trial NCT03918148: Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)
Official title: Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 1150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women with type 2 diabetes attending diabetes centers of the Campanian county treated with metformin and/or basal insulin who start therapy with a SGLT-2i or DPP-4i according to the clinical practice.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Type 1 diabetes or secondary diabetes resulting from specific causes
* History of neurovascular ulcers
* Previous therapy with SGLT-2i or DPP4-i in the 3 months prior to the study enrollment
* History of cancer within the last 5 years
* Pregnancy or active breast-feeding
* Serum creatinine level ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
* eGFR ≤ 60 ml/min/1.73 m2

Primary outcomes:
measure: Carotid intima-media thickness (CIMT)
timeFrame: 24 months
measure: Myocardial stiffness indexes
timeFrame: 24 months
measure: Urinary albumin to creatinine ratio excretion
timeFrame: 24 months
Secondary outcomes:
measure: Weight
timeFrame: 24 months
measure: Body mass index (BMI)
timeFrame: 24 months
measure: Waist circumference (WC)
timeFrame: 24 months
measure: Blood pressure
timeFrame: 24 months
measure: estimated Glomerular filtration rate (eGFR)
timeFrame: 24 months
Other outcomes:
measure: HbA1c
timeFrame: 24 months
measure: Mean amplitude glucose excursions (MAGE)
timeFrame: 24 months
measure: Lipid profile
timeFrame: 24 months
Locations:
city: Naples
country: Italy
facility: Unit of Diabetes
state: Campania
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Katherine Esposito
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Dario Giugliano
role: STUDY_DIRECTOR
References:
citation: Giugliano D, Maiorino MI, Longo M, Esposito K. Are gliflozins the new statins for diabetes? Diabetes Res Clin Pract. 2019 Jul;153:191-193. doi: 10.1016/j.diabres.2019.04.014. Epub 2019 Apr 5. No abstract available.
citation: Giugliano D, Maiorino MI, Bellastella G, Esposito K. Glycemic control in type 2 diabetes: from medication nonadherence to residual vascular risk. Endocrine. 2018 Jul;61(1):23-27. doi: 10.1007/s12020-017-1517-9. Epub 2018 Jan 10.
citation: Esposito K, Longo M, Maiorino MI, Petrizzo M, Gicchino M, Bellastella G, Giugliano D. Metabolic effectiveness of gliflozins and gliptins in the routine clinical practice of patients with type 2 diabetes: preliminary results from GIOIA, a prospective multicentre study. Diabetes Res Clin Pract. 2019 Sep;155:107787. doi: 10.1016/j.diabres.2019.107787. Epub 2019 Jul 19.
citation: Longo M, Scappaticcio L, Maiorino MI, De Nicola L, Bellastella G, Esposito K. Renal and metabolic effects of SGLT-2i and DPP-4i according to basal estimated glomerular filtration rate: Analysis from GIOIA, an observational prospective study. Diabetes Res Clin Pract. 2021 Aug;178:108990. doi: 10.1016/j.diabres.2021.108990. Epub 2021 Jul 29.
citation: Longo M, Caruso P, Scappaticcio L, Maiorino MI, Bellastella G, Capuano A, Esposito K, Giugliano D. Two years with GIOIA 'Effects of gliflozins and gliptins on markers of cardiovascular damage in type 2 diabetes': A prospective, multicentre, quasi-experimental study on sodium-glucose cotransporter 2 and dipeptidyl peptidase-4 inhibitors in diabetes clinical practice. Diabetes Obes Metab. 2024 Apr;26(4):1492-1501. doi: 10.1111/dom.15451. Epub 2024 Jan 17.