Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)
NCT03918148 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1150
Last updated 2024-04-19
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.
Conditions
Interventions
- DRUG
-
SGLT-2i
Dapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin
- DRUG
-
DPP-4i
Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin
Sponsors & Collaborators
-
University of Campania Luigi Vanvitelli
lead OTHER
Principal Investigators
-
Katherine Esposito · University of Campania Luigi Vanvitelli
-
Dario Giugliano · University of Campania Luigi Vanvitelli
Eligibility
- Min Age
- 35 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-15
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
- FDA Drug
- Yes
Countries
- Italy
Study Locations
More Related Trials
-
Comparative Effectiveness of Dapagliflozin Versus DPP-4 Inhibitors
NCT04304430 ·Status: COMPLETED
-
SGLT-2 and DPP-4 Inhibition, Subclinical Inflammation of the Genito-urinary Tract and Risk of Infections.
NCT04735042 ·Status: COMPLETED
-
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
NCT02700334 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Empagliflozin on Body Composition and Ketones
NCT03877406 ·Status: UNKNOWN ·Phase: PHASE4
-
Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists
NCT04184947 ·Status: COMPLETED
-
Effects of SGLT2 Inhibitors on Islet Cell Function and Insulin Sensitivity in Patients of Type 2 Diabetes Mellitus
NCT04014192 ·Status: UNKNOWN ·Phase: PHASE4
-
Effects of SGLT2 Inhibitor in Diabetic Patients With Coronary Artery Disease
NCT03398577 ·Status: UNKNOWN ·Phase: PHASE4
-
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
NCT02113241 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes
NCT05109949 ·Status: UNKNOWN ·Phase: PHASE3
-
Use of Incretins in Diabetic Patients
NCT03486964 ·Status: COMPLETED
-
Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes
NCT05457933 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Dapagliflozin on Hormonal Glucose Homeostasis in Type 1 Diabetes
NCT04035031 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
NCT03310944 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of SGLT-2 Inhibitor Dapagliflozin on Glycemic Variability in Patients With Diabetes Mellitus Type 2
NCT02719756 ·Status: UNKNOWN ·Phase: PHASE4
-
Dapagliflozin Effects on Hypoglycemia
NCT03704818 ·Status: COMPLETED ·Phase: PHASE1
-
Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors and Risk of Cardiovascular Events
NCT03939624 ·Status: COMPLETED
-
To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin
NCT05162014 ·Status: COMPLETED
-
Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
NCT04149067 ·Status: COMPLETED
-
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
NCT00642278 ·Status: COMPLETED ·Phase: PHASE2
-
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
NCT02681094 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
NCT00937326 ·Status: COMPLETED ·Phase: PHASE2
-
Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients
NCT03071016 ·Status: COMPLETED
-
A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
NCT02025907 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Empagliflozin on Liver Fat Content in Patients With Type 2 Diabetes
NCT02686476 ·Status: COMPLETED ·Phase: NA
-
Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.
NCT07019012 ·Status: RECRUITING ·Phase: PHASE4