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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

SGLT-2i

Intervention Type DRUG

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

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

DPP-4i

Intervention Type DRUG

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

Interventions

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SGLT-2i

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

Intervention Type DRUG

DPP-4i

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No