Skip to main content
OpenTrials
Completed

NCT Number: NCT03918148

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit of Diabetes

Naples, Campania, 80138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGLT-2i

Drug

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

DPP-4i

Drug

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

Primary outcomes

  1. Carotid intima-media thickness (CIMT)

    Time frame: 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

  2. Myocardial stiffness indexes

    Time frame: 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

  3. Urinary albumin to creatinine ratio excretion

    Time frame: 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

Secondary outcomes

  1. Weight

    Time frame: 24 months

    Change in body weight in kilograms (kg) from baseline

  2. Body mass index (BMI)

    Time frame: 24 months

    Change in body mass index in Kg/mq from baseline

  3. Waist circumference (WC)

    Time frame: 24 months

    Change in waist circumference in cm from baseline

  4. Blood pressure

    Time frame: 24 months

    Change in systolic and dyastolic blood pressure in mmHg from baseline

  5. estimated Glomerular filtration rate (eGFR)

    Time frame: 24 months

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

Other outcomes

  1. HbA1c

    Time frame: 24 months

    Change in HbA1c in % from baseline

  2. Mean amplitude glucose excursions (MAGE)

    Time frame: 24 months

    Change in MAGE in mmol/L from baseline

  3. Lipid profile

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study

Acronym: GIOIA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2019
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.