Peripheral Artery Disease and type 2 diabetes mellitus MedDRA version: 20.0 Level: LLT Classification code 10053246 Term: Type II diabetes peripheral angiopathy System Organ Class: 100000004866
Conditions
Interventions
Trade Name: VICTOZA - 6 MG/ML-SOLUZIONE INIETTABILE IN PENNA PRERIEMPITA - USO SOTTOCUTANEO - CARTUCCIA(VETRO) IN PENNA PRERIEMPITA - 3ML 2 PENNE PRERIEMPITE
Product Name: Liraglutide
Product Code: [N
Sponsors
A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with type 2 diabetes, peripheral artery disease with transcutaneous oxygen tension on lower limbs between 49 and 30 mmHg and with: - HbA1c 6.5% - 8%. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Type 1 diabetes or diabetes secondary to specific causes Previous treatment (within the last 3 months) with a GLP-1RA or a DPP-4 inhibitor Contraindications to the use of GLP-1RA (pancreatitis) Pregnancy or pregnancy scheduled during the study period Planned vascular revascularization GFR <15 ml/min History of cancer or anti-neoplastic therapy in the 5 years prior to randomization Current therapy with oral, topical or systemic glucocorticoids, or with atypical antipsychotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the STARDUST study is to evaluate the effects of liraglutide, as compared with conventional care, on the peripheral oxygen perfusion defined as transcutaneous oxygen tension of the anterior tibial artery in patients with type 2 diabetes and peripheral artery.;Secondary Objective: 1. glycemic control parameters (fasting blood glucose and Hba1c, weight, body mass index, waist circumference, blood pressure) 2. lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) 3. inflammation markers (C reactive protein, fibrinogen, TNF-a and IL-6) 4. renal function (serum creatinine, azotemia, albuminuria, glomerular filtration rate) 5. angiogenesis biomarkers (endothelial progenitors cells and vascular endothelial growth factor) 6. autonomic neuropathy (evaluation of the foot sudomotor activity) The following parameters will also be evaluated: 7. change of sexual hormones (testosterone/estradiol, FSH, LH and SHBG) 8. change of sexual function questionnaire (International Index of Erectile Function (IIEF-5) men; Female Sexual Function Index (FSFI) for women).;Primary end point(s): Variation of TcPO2 levels on lower limbs intended as an increase of 10% in the liraglutide group compared to the levels measured at baseline.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Variation of: 1. glycemic control parameters (fasting blood glucose and Hba1c, weight, body mass index, waist circumference, blood pressure) 2. lipid structure (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) 3. inflammation markers (C reactive protein, fibrinogen, TNF-a and IL-6) 4. renal function (serum creatinine, azotemia, albuminuria, glomerular filtration rate) 5. angiogenesis biomarkers (Endothelial Progenitors Cells and vascular endothelial growth factor) 6. autonomic neuropathy (evaluation of the foot sudomotor activity) The following changes will also be evaluated: 7. sexual hormones (testosterone/estradiol, FSH, LH and SHBG) 8. sexual function questionnaire (International Index of Erectile Function (IIEF-5) men; Female Sexual Function Index (FSFI) for women).;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Italy
Contacts
Public ContactUOC Endocrinologia e Malattie del M
AOU Università degli Studi della Campania "L. Vanvitelli"
Outcome results
None listed