Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus

PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 3, 2017

Primary Completion Date

September 15, 2018

Study Completion Date

September 15, 2018

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Other

"Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2.~Then, subjects will be discharged at the end of the last investigation day (Day 2).~All the participants have received two pharmacological agents (NIMP) :~* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.~* Adenosine : administered intravenously during MRI for the measurement of CFR."

DRUG

Other

"Type 2 diabetic patients will be selected within 3 weeks before inclusion (Day 0).~The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and CFR on Day 2.~Then, subjects will be discharged at the end of the last investigation day (Day 2).~All the participants have received two pharmacological agents (NIMP):~* Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.~* Adenosine : administered intravenously during MRI for the measurement of CFR."

Trial Locations (1)

89231

Nuvisan GmbH, Neu-Ulm

All Listed Sponsors
collaborator

ADIR, a Servier Group company

INDUSTRY

lead

Institut de Recherches Internationales Servier

OTHER

NCT04744636 - Vascular Function and Biomarker Assessments in Healthy Volunteers and in Patients With Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter