Type 2 Diabetes MellitusGIOIANCT03918148
Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)
An observational study of Type 2 Diabetes Mellitus, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SGLT-2i and DPP-4i
- Type of treatment
- Pill or oral medicine
- How many people
- 1,150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SGLT-2i, DPP-4i
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2iDrug
Dapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin
DPP-4iDrug
Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: DPP-4i |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24 months
Secondary outcomes (5)
Weight
Change in body weight in kilograms (kg) from baseline
Measured: 24 months
Body mass index (BMI)
Change in body mass index in Kg/mq from baseline
Measured: 24 months
Waist circumference (WC)
Change in waist circumference in cm from baseline
Measured: 24 months
Blood pressure
Change in systolic and dyastolic blood pressure in mmHg from baseline
Measured: 24 months
estimated Glomerular filtration rate (eGFR)
Change in estimated glomerular filtration rate in mI/min/1.73 mq from baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start15 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Esposito, University of Campania Luigi Vanvitelli
- Investigators
- Katherine Esposito, Principal investigator, University of Campania Luigi VanvitelliDario Giugliano, Study director, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918148
- Sponsor's protocol ID
- 2193/2018
- Acronym
- GIOIA
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2019
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30959149Giugliano 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.
PubMed 29322300Esposito 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.
PubMed 31326454Longo 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.
PubMed 34333059Longo 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.
PubMed 38234208
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gliflozins on Markers of Cardiovascular Risk in Type 2 Diabetes (GIOIA): a Multicenter Pragmatic Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03918148
- Acronym / sponsor ID
- GIOIA / 2193/2018
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT-2i | – | Drug: SGLT-2iType 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 |
| DPP-4i | – | Drug: DPP-4iType 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 |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2iDapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin | Drug | SGLT-2i |
| DPP-4iSitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin | Drug | DPP-4i |
Primary outcome
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
5 secondary outcomes
Weight
Time frame: 24 months
Body mass index (BMI)
Time frame: 24 months
Waist circumference (WC)
Time frame: 24 months
Blood pressure
Time frame: 24 months
estimated Glomerular filtration rate (eGFR)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 30959149Giugliano 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.
- Background: PubMed 29322300Giugliano 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.
- Background: PubMed 31326454Esposito 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.
- Background: PubMed 34333059Longo 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.
- Background: PubMed 38234208Longo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Esposito principal investigator
University of Campania Luigi Vanvitelli
Dario Giugliano study director
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid intima-media thickness (CIMT) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918148, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.