Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,150
- 试验地点
- 1
- 主要终点
- Urinary albumin to creatinine ratio excretion
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: SGLT-2i (Drug)
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
干预措施: DPP-4i (Drug)
结局指标
主要结局
Urinary albumin to creatinine ratio excretion
时间窗: 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)
时间窗: 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
时间窗: 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
次要结局
- Blood pressure(24 months)
- Waist circumference (WC)(24 months)
- estimated Glomerular filtration rate (eGFR)(24 months)
- Body mass index (BMI)(24 months)
- Weight(24 months)
研究者
Katherine Esposito
Full Professor of Endocrinology and Metabolic Diseases
University of Campania "Luigi Vanvitelli"