Trials / Completed
CompletedNCT03462017
Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus
Study to Assess the Pharmacodynamic Effects of Repeated Oral Doses of SAR247799 on Endothelial Function in Male and Female Patients With Type 2 Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Study duration per patient is approximately 10 weeks including a 4-week treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-03-07
- Primary completion
- 2018-12-22
- Completion
- 2018-12-22
- First posted
- 2018-03-12
- Last updated
- 2022-04-25
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03462017. Inclusion in this directory is not an endorsement.