Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGSGLT-2i
Dapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin
DRUGDPP-4i
Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin
Sponsors
University of Campania Luigi Vanvitelli
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 24 months | Change in systolic and dyastolic blood pressure in mmHg from baseline |
| estimated Glomerular filtration rate (eGFR) | 24 months | Change in estimated glomerular filtration rate in mI/min/1.73 mq from baseline |
| Waist circumference (WC) | 24 months | Change in waist circumference in cm from baseline |
| Weight | 24 months | Change in body weight in kilograms (kg) from baseline |
| Body mass index (BMI) | 24 months | Change in body mass index in Kg/mq from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 24 months | Change in HbA1c in % from baseline |
| Lipid profile | 24 months | Change in total cholesterol, tryglicerides, HDL-cholesterol, and LDL-cholesterol in mg/dL from baseline |
| Mean amplitude glucose excursions (MAGE) | 24 months | Change in MAGE in mmol/L from baseline |
Countries
Italy
Outcome results
None listed