NCT03918148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,150

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

6 years

First QC Date

April 9, 2019

Last Update Submit

April 16, 2024

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • 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

    24 months

  • 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

    24 months

  • 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

    24 months

Secondary Outcomes (5)

  • Weight

    24 months

  • Body mass index (BMI)

    24 months

  • Waist circumference (WC)

    24 months

  • Blood pressure

    24 months

  • estimated Glomerular filtration rate (eGFR)

    24 months

Other Outcomes (3)

  • HbA1c

    24 months

  • Mean amplitude glucose excursions (MAGE)

    24 months

  • Lipid profile

    24 months

Study Arms (2)

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

SGLT-2iDRUG

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

SGLT-2i
DPP-4iDRUG

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

DPP-4i

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Diabetes

Naples, Campania, 80138, Italy

Location

Related Publications (5)

  • 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.

    PMID: 30959149BACKGROUND

  • 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.

    PMID: 29322300BACKGROUND

  • 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.

    PMID: 31326454BACKGROUND

  • 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.

    PMID: 34333059BACKGROUND

  • 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.

    PMID: 38234208BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Katherine Esposito

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

  • Dario Giugliano

    University of Campania Luigi Vanvitelli

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Endocrinology and Metabolic Diseases

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 17, 2019

Study Start

January 15, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)