EFFECTS OF THE GLP-1 RECEPTOR AGONIST LIRAGLUTIDE ON LOWER LIMB PERFUSION IN PEOPLE WITH TYPE 2 DIABETES AND PERIPHERAL ARTERY DISEASE: A RANDOMIZED CONTROLLED TRIA

Phase 1

• Conditions: Peripheral Artery Disease and type 2 diabetes mellitus; MedDRA version: 20.0Level: LLTClassification code 10053246Term: Type II diabetes peripheral angiopathySystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-002940-22-IT
• Lead Sponsor: A.O.U. Università degli Studi della Campania Luigi Vanvitelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified