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CompletedNCT03918148GIOIAUpdated Apr 19, 2024

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

An observational study in Type 2 Diabetes Mellitus, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by University of Campania Luigi Vanvitelli · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,150
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,150 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Men and women with type 2 diabetes attending diabetes centers of the Campanian county treated with metformin and/or basal insulin who start therapy with a SGLT-2i or DPP-4i according to the clinical practice.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,150 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    Drug: SGLT-2i

  • 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

    Drug: DPP-4i

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Weight

    Change in body weight in kilograms (kg) from baseline

    Time frame: 24 months

  2. Body mass index (BMI)

    Change in body mass index in Kg/mq from baseline

    Time frame: 24 months

  3. Waist circumference (WC)

    Change in waist circumference in cm from baseline

    Time frame: 24 months

  4. Blood pressure

    Change in systolic and dyastolic blood pressure in mmHg from baseline

    Time frame: 24 months

  5. estimated Glomerular filtration rate (eGFR)

    Change in estimated glomerular filtration rate in mI/min/1.73 mq from baseline

    Time frame: 24 months

Other outcomes

  1. HbA1c

    Change in HbA1c in % from baseline

    Time frame: 24 months

  2. Mean amplitude glucose excursions (MAGE)

    Change in MAGE in mmol/L from baseline

    Time frame: 24 months

  3. Lipid profile

    Change in total cholesterol, tryglicerides, HDL-cholesterol, and LDL-cholesterol in mg/dL from baseline

    Time frame: 24 months

07

Study locations

1 site
  • Unit of Diabetes
    Naples, Campania 80138, Italy
08

References and documents

Publications

  • Giugliano D, Maiorino MI, Longo M, Esposito K. Are gliflozins the new statins for diabetes? Diabetes Res Clin Pract. 2019 Jul;153:191-193. doi: 10.1016/j.diabres.2019.04.014. Epub 2019 Apr 5. No abstract available. PubMed 30959149 ↗
  • Giugliano D, Maiorino MI, Bellastella G, Esposito K. Glycemic control in type 2 diabetes: from medication nonadherence to residual vascular risk. Endocrine. 2018 Jul;61(1):23-27. doi: 10.1007/s12020-017-1517-9. Epub 2018 Jan 10. PubMed 29322300 ↗
  • Esposito K, Longo M, Maiorino MI, Petrizzo M, Gicchino M, Bellastella G, Giugliano D. Metabolic effectiveness of gliflozins and gliptins in the routine clinical practice of patients with type 2 diabetes: preliminary results from GIOIA, a prospective multicentre study. Diabetes Res Clin Pract. 2019 Sep;155:107787. doi: 10.1016/j.diabres.2019.107787. Epub 2019 Jul 19. PubMed 31326454 ↗
  • Longo M, Scappaticcio L, Maiorino MI, De Nicola L, Bellastella G, Esposito K. Renal and metabolic effects of SGLT-2i and DPP-4i according to basal estimated glomerular filtration rate: Analysis from GIOIA, an observational prospective study. Diabetes Res Clin Pract. 2021 Aug;178:108990. doi: 10.1016/j.diabres.2021.108990. Epub 2021 Jul 29. PubMed 34333059 ↗
  • Longo M, Caruso P, Scappaticcio L, Maiorino MI, Bellastella G, Capuano A, Esposito K, Giugliano D. Two years with GIOIA 'Effects of gliflozins and gliptins on markers of cardiovascular damage in type 2 diabetes': A prospective, multicentre, quasi-experimental study on sodium-glucose cotransporter 2 and dipeptidyl peptidase-4 inhibitors in diabetes clinical practice. Diabetes Obes Metab. 2024 Apr;26(4):1492-1501. doi: 10.1111/dom.15451. Epub 2024 Jan 17. PubMed 38234208 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03918148
Lead sponsor
University of Campania Luigi Vanvitelli
Responsible party
Katherine Esposito (Full Professor of Endocrinology and Metabolic Diseases, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
Apr 17, 2019
Start date
Jan 15, 2018
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Apr 19, 2024

Study contacts

Katherine Esposito
principal investigator · University of Campania Luigi Vanvitelli
Dario Giugliano
study director · University of Campania Luigi Vanvitelli

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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