Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)

Type 2 Diabetes Mellitus Clinical Trial

— GIOIA  

Official title:

Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918148
• Other study ID #: 2193/2018
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• SGLT-2i
Dapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin
• DPP-4i
Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin

Locations

Country	Name	City	State
Italy	Unit of Diabetes	Naples	Campania

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1c	Change in HbA1c in % from baseline	24 months
Other	Mean amplitude glucose excursions (MAGE)	Change in MAGE in mmol/L from baseline	24 months
Other	Lipid profile	Change in total cholesterol, tryglicerides, HDL-cholesterol, and LDL-cholesterol in mg/dL from baseline	24 months
Primary	Carotid intima-media thickness (CIMT)	Progression (increase in mean CIMT in millimeters [mm]) or regression (reduction > o = 0.020 mm on mean CIMT) after 2 years of follow-up	24 months
Primary	Myocardial stiffness indexes	Change from baseline in: Left Ventricular Ejection Fraction (LVEF) in percentage (%), Diastolic Left Ventricular Dimension (LVDs) in centimeters (cm) Interventricular Septum thickness (IVS) in cm left vetricular posterior wall thickness (PWs) in cm	24 months
Primary	Urinary albumin to creatinine ratio excretion	Development of microalbuminuria in normoalbuminuric patients at baseline or development of macroalbuminuria in patients with microalbuminuria at baseline; regression of microalbuminuria to normoalbuminuria or regression of macroalbuminuria to microalbuminuria	24 months
Secondary	Weight	Change in body weight in kilograms (kg) from baseline	24 months
Secondary	Body mass index (BMI)	Change in body mass index in Kg/mq from baseline	24 months
Secondary	Waist circumference (WC)	Change in waist circumference in cm from baseline	24 months
Secondary	Blood pressure	Change in systolic and dyastolic blood pressure in mmHg from baseline	24 months
Secondary	estimated Glomerular filtration rate (eGFR)	Change in estimated glomerular filtration rate in mI/min/1.73 mq from baseline	24 months