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出境医 / 临床实验 / Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA) (GIOIA)
Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA) (GIOIA)
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 |
|---|---|
| Type 2 Diabetes Mellitus | Drug: SGLT-2i Drug: DPP-4i |
Study Design
| 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 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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
- 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
- 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 :
- Weight [ Time Frame: 24 months ]Change in body weight in kilograms (kg) from baseline
- Body mass index (BMI) [ Time Frame: 24 months ]Change in body mass index in Kg/mq from baseline
- Waist circumference (WC) [ Time Frame: 24 months ]Change in waist circumference in cm from baseline
- Blood pressure [ Time Frame: 24 months ]Change in systolic and dyastolic blood pressure in mmHg from baseline
- 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:
- HbA1c [ Time Frame: 24 months ]Change in HbA1c in % from baseline
- Mean amplitude glucose excursions (MAGE) [ Time Frame: 24 months ]Change in MAGE in mmol/L from baseline
- Lipid profile [ Time Frame: 24 months ]Change in total cholesterol, tryglicerides, HDL-cholesterol, and LDL-cholesterol in mg/dL from baseline
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Katherine Esposito | +39 0815665031 | katherine.esposito@unicampania.it |
Locations
| 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
| Principal Investigator: | Katherine Esposito | University of Campania "Luigi Vanvitelli" | |
| Study Director: | Dario Giugliano | University of Campania "Luigi Vanvitelli" |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | April 9, 2019 | ||||||
| First Posted Date | April 17, 2019 | ||||||
| Last Update Posted Date | April 17, 2019 | ||||||
| Actual Study Start Date | January 15, 2018 | ||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||
| Descriptive Information | |||||||
| Brief Title | Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA) | ||||||
| Official Title | Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study | ||||||
| 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| 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. | ||||||
| Condition | Type 2 Diabetes Mellitus | ||||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Recruiting | ||||||
| Estimated Enrollment |
555 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | December 31, 2025 | ||||||
| Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 35 Years to 75 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | Italy | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03918148 | ||||||
| Other Study ID Numbers | 2193/2018 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Katherine Esposito, University of Campania "Luigi Vanvitelli" | ||||||
| Study Sponsor | University of Campania "Luigi Vanvitelli" | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | University of Campania "Luigi Vanvitelli" | ||||||
| Verification Date | April 2019 | ||||||
