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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: SGLT-2i; Drug: DPP-4i

• Registration Number: NCT03918148
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-13
• Study First Posted: 2019-04-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SGLT-2i	SGLT-2i	Type 2 diabetic patients treated with metformin and/or insulin starting therapy with a SGLT-2 inhibitor: dapagliflozin 10 mg, oral, once daily or canagliflozin 100 mg, oral, daily or empagliflozin 10 mg, oral, daily
DPP-4i	DPP-4i	Type 2 diabetic patients treated with metformin and/or insulin starting therapy with a DPP-4 inhibitor: sitagliptin 100 mg, oral once daily or vildagliptin 50 mg, oral, twice daily or saxaglitpin 5 mg, oral, once daily or linagliptin 5 mg, oral, once daily or alogliptin 25 mg, oral, once daily

Primary Outcome Measures

Name	Time	Method
Urinary albumin to creatinine ratio excretion	24 months	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
Carotid intima-media thickness (CIMT)	24 months	Progression (increase in mean CIMT in millimeters \[mm\]) or regression (reduction \> o = 0.020 mm on mean CIMT) after 2 years of follow-up
Myocardial stiffness indexes	24 months	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

Secondary Outcome Measures

Name	Time	Method
Blood pressure	24 months	Change in systolic and dyastolic blood pressure in mmHg from baseline
Waist circumference (WC)	24 months	Change in waist circumference in cm from baseline
estimated Glomerular filtration rate (eGFR)	24 months	Change in estimated glomerular filtration rate in mI/min/1.73 mq from baseline
Body mass index (BMI)	24 months	Change in body mass index in Kg/mq from baseline
Weight	24 months	Change in body weight in kilograms (kg) from baseline

Trial Locations

Locations (1)

Unit of Diabetes; 🇮🇹 Naples, Campania, Italy