Clincosm LogoSign in Get a demo

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

Sponsor
University of Campania "Luigi Vanvitelli" (Other)
Overall Status
Recruiting
CT.gov ID
NCT03918148
Collaborator
(none)
555
Enrollment
1
Location
95.5
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Study Design

Study Type:
Observational
Anticipated 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 :
Jan 15, 2018
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Carotid intima-media thickness (CIMT) [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 [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 [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 [24 months]

    Change in body weight in kilograms (kg) from baseline

  2. Body mass index (BMI) [24 months]

    Change in body mass index in Kg/mq from baseline

  3. Waist circumference (WC) [24 months]

    Change in waist circumference in cm from baseline

  4. Blood pressure [24 months]

    Change in systolic and dyastolic blood pressure in mmHg from baseline

  5. estimated Glomerular filtration rate (eGFR) [24 months]

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

Other Outcome Measures

  1. HbA1c [24 months]

    Change in HbA1c in % from baseline

  2. Mean amplitude glucose excursions (MAGE) [24 months]

    Change in MAGE in mmol/L from baseline

  3. Lipid profile [24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unit of Diabetes Naples Campania Italy 80138

Sponsors and Collaborators

  • University of Campania "Luigi Vanvitelli"

Investigators

  • Principal Investigator: Katherine Esposito, University of Campania "Luigi Vanvitelli"
  • Study Director: Dario Giugliano, University of Campania "Luigi Vanvitelli"

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Katherine Esposito, Full Professor of Endocrinology and Metabolic Diseases, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier:
NCT03918148
Other Study ID Numbers:
  • 2193/2018
First Posted:
Apr 17, 2019
Last Update Posted:
Apr 17, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 17, 2019