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

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ClinicalTrials.gov Identifier: NCT03918148
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Esposito, University of Campania "Luigi Vanvitelli"

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: SGLT-2i Drug: DPP-4i

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Study Type : Observational
Estimated Enrollment : 555 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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

Drug: DPP-4i
Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918148


Contacts
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Contact: Katherine Esposito +39 0815665031 katherine.esposito@unicampania.it

Locations
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Italy
Unit of Diabetes Recruiting
Naples, Campania, Italy, 80138
Contact: Katherine Esposito    +39 0815665005    katherine.esposito@unicampania.it   
Sub-Investigator: Maria Ida Maiorino         
Sub-Investigator: Michela Petrizzo         
Sub-Investigator: Maurizio Gicchino         
Sub-Investigator: Miriam Longo         
Sub-Investigator: Giuseppe Bellastella         
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
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Principal Investigator: Katherine Esposito University of Campania "Luigi Vanvitelli"
Study Director: Dario Giugliano University of Campania "Luigi Vanvitelli"

Publications:
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Responsible Party: Katherine Esposito, Full Professor of Endocrinology and Metabolic Diseases, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03918148     History of Changes
Other Study ID Numbers: 2193/2018
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Sodium-Glucose Transporter 2 Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action