Patients with diabetes mellitus type 2
Conditions
Interventions
Trade Name: JARDIANCE - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 28 COMPRESSE
Product Code: [JARDIANCE 25 mg 28 compresse]
Pharmaceutical Form:
Trade Name: HUMULIN -
Sponsors
FONDAZIONE TOSCANA GABRIELE MONASTERIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Type 2 diabetic patients, age = 18 and = 64 years, male and female, BMI 20-40 kg/m2, HbA1c 6.5-10.5%, on diet and exercise regimen, or on therapy with stable dose of metformin, sulphonylurea (ATC A10BB), DPP4-inhibitors (ATC A10BH) and GLP-1 agonists (i.e. liraglutide, albiglutide, exenantide) or their combinations, signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Patients on insulin or on thiazolidinediones (i.e. pioglitazone) and SGLT2 inhibitors (i.e. canagliflozin, dapagliflozin, empagliflozin), subjects with hepatic and renal disease, pregnancy and childbearing potential, alcohol or drug abuse, concomitant use of drugs that may increase or decrease the activity of the metabolizing enzymes of the cytochrome P450, hypersensitivity to the active substances of the study drugs or to any of their excipients or known pre-existing contraindication tothe administration of the experimental study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. to measure glycosuria in type 2 diabetic patients during hyperglycaemia 2. to investigate the effect of physiological hyperinsulinaemia on renal glucose excretion in patients with type 2 diabetes. 3. to test the effect of empagliflozin on renal glucose excretion in diabetic patients and to test whether any renal effect of insulin is synergic with SGLT-2 inhibition by empagliflozin.;Secondary Objective: 1. to investigate whether any difference in creatinine clearance, as well as in measured glomerular filtration rate is present among the three studies conditions (hyperglycemia [CT period] vs hyperglycemia/hyperinsulinemia [INS1 period] vs hyperglycemia/hyperinsulinemia/SGLT2 inhibition [EMPA period]) in diabetic patients.;Primary end point(s): 1. glucose excretion in 180 minutes during CT period from urinary glucose sample in diabetic patients during hyperglycemia; 2. glucose excretion in 180 minutes during INS1 period (from urinary sample) in diabetic patients; 3. glucose excretion in 180 minutes during EMPA period and glucose excretion in 180 minutes during INS1 period from urinary sample in diabetic patients.;Timepoint(s) of evaluation of this end point: 180 minutes for each study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in glomerular filtration rate measured as creatinine clearance in the three studies periods CT, EMPA and INS1 (a difference < 5-10% is expected). | — |
Countries
Italy
Contacts
Public ContactUO Farmaceutica Ospedaliera
Fondazione Toscana Gabriele Monasterio
Outcome results
None listed