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

University of Campania Luigi Vanvitelli1,150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,150

Conditions

Type 2 Diabetes Mellitus

Interventions

SGLT-2iDRUG

Dapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin

DPP-4iDRUG

Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Unit of Diabetes

Naples, Campania, Italy

Outcomes

Primary Outcomes

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

Time frame: 24 months

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

Time frame: 24 months

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

Time frame: 24 months

Secondary Outcomes

Weight

Change in body weight in kilograms (kg) from baseline

Time frame: 24 months

Body mass index (BMI)

Change in body mass index in Kg/mq from baseline

Time frame: 24 months

Waist circumference (WC)

Change in waist circumference in cm from baseline

Time frame: 24 months

Blood pressure

Change in systolic and dyastolic blood pressure in mmHg from baseline

Time frame: 24 months

Data from ClinicalTrials.gov

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