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Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus

NCT03462017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary Objective:

To assess the pharmacodynamic effects of SAR247799 on macrovascular endothelial function of the brachial artery using flow-mediated dilation (FMD) in patients with type 2 diabetes mellitus (T2DM).

Secondary Objective:

* To assess the pharmacodynamic effects of SAR247799 on microvascular endothelial function using laser Doppler perfusion monitoring in patients with T2DM.
* To assess the safety profile of SAR247799 in patients with T2DM.
* To assess the plasma pharmacokinetic profile of SAR247799 in patients with T2DM.

Conditions

  • Microvascular Coronary Artery Disease

Interventions

DRUG

SAR247799

Pharmaceutical form:Capsule Route of administration: Oral

DRUG

Placebo

Pharmaceutical form:Capsule Route of administration: Oral

DRUG

Sildenafil

Pharmaceutical form:Encapsulated tablet Route of administration: Oral

DRUG

Acetylcholine

Pharmaceutical form:Solution Route of administration: Transdermal

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2018-12-22
Completion
2018-12-22

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462017 on ClinicalTrials.gov