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

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: DPP-4i; Drug: SGLT-2i

Study type: Observational

Funder types: Other

Identifiers

NCT03918148

2193/2018

Details and patient eligibility

About

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.

Enrollment: 1,150 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,150 participants in 2 patient groups

SGLT-2i

Description:

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

Treatment:

Drug: SGLT-2i

DPP-4i

Description:

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

Treatment:

Drug: DPP-4i