Diabetes mellitus type 2 MedDRA version: 21.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Bydureon
Product Name: Bydureon
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Januvia
Pharmaceutical Form: Film-coated tablet
Sponsors
UNIVERSITÀ DEGLI STUDI "G. D'ANNUNZIO" CHIETI-PESCARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study subjects should fulfill the following criteria: 1. Provision of informed consent prior to any study specific procedures 2. White/Caucasian Female or male aged between 40 and 70 years 3. T2DM diagnosed since at least 2 years; 4. Baseline HbA1c between 7.5 and 9% (as incretin based therapy reimbursement drug starting range in Italy); 5. Diabetes and Cardiovascular risk factors treatment unchanged during the last 3 months; 6. Not treated with DPP-IV inhibitors or GLP-Rxs during the last 6 months; 7. Not treated with SGLT-2 inhibitors during the last 6 months; 8. On a stable dose of metformin (at least 1000mg/qd) since at least 3 months 9. On stable Basal insulin therapy (glargine) + 10% since at least 3 months; 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 1. Baseline HbA1c between 9.0%; 2. T1DM or T2DM diagnosed less than 2 years; 3. Not White/Caucasian aged below 40 and over 70 years 4. Diabetes and Cardiovascular risk factors treatment changed during the last 3 months; 5. Treated with DPP-IV inhibitors or GLP-Rxs during the last 6 months; 6. Treated with SGLT-2 inhibitors during the last 6 months; 7. On different therapy than Basal insulin therapy (glargine) + OAD since at least 3 months; 8. Previous Cardiovascular Events; 9. Known disease of the immune system. 10. Known or suspected hypersensitivity to the trial product or related products. 11. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice. 12. Participation in another clinical trial of an investigational medicinal product. Participation in a clinical trial which evaluate stent(s) is allowed. 13. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol. 14. History of pancreatitis (acute or chronic). 15. Planned coronary, carotid or peripheral artery revascularization known on the day of screening. 16. Chronic or intermittent hemodialysis or peritoneal dialysis or moderate renal impairment (corresponding to eGFR <50 mL/min/1.73 m2). 17. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ). 18. History of diabetic ketoacidosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in EMVs levels as markers of endothelial dysfunction at week 38 compared to baseline;Secondary Objective: -Change in HbA1c at week 38 compared to baseline -Change in FPG, PPG at week 38 compared to baseline -Change in BMI at week 38 compared to baseline -Change in EPCs levels as markers of endothelial function at week 38 compared to baseline. -Change in frequency of hypoglycemic episodes and AE during the study, between the two group of treatment -Change in glucose variability indexes (SD, MAGE, CONGA) from baseline to Week 38 assessed by CGM in a subgroup of patients both in the exenatide and sitagliptin arm. -Change in and body composition, Visceral/subcutaneous fat from baseline to Week 38 assessed by MRI in a subgroup of patients both in the exenatide and sitagliptin arm;Primary end point(s): Change in EMVs levels as markers of endothelial dysfunction at week 38 compared to baseline;Timepoint(s) of evaluation of this end point: baseline and 38 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in HbA1c from baseline to Week 38, in FPG, PPG from baseline to Week 38, in BMI and body composition from baseline to Week 38. ; Safety objective: Change in frequency of hypoglycemic episodes and AE from baseline to Week 38 ; Exploratory objectives: Change in glucose variability indexes (SD, MAGE, CONGA) from baseline to Week 38 assessed by CGM in a subgroup of patients both in the exenatide and sitagliptin arm and change in Visceral/subcutaneous fat from baseline to Week 38 assessed by MRI in a subgroup of patients both in the exenatide and sitagliptin arm; Change in EPCs levels as markers of endothelial function at week 38 compared to baseline;Timepoint(s) of evaluation of this end point: 38 weeks; 38 weeks; 38 weeks; baseline and 38 weeks | — |
Countries
Italy
Contacts
Public ContactDott. Fabrizio Febo
UOC territoriale di Endocrinologia e Malattie del Metabolismo
Outcome results
None listed