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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Change in Flow Mediated Dilation (FMD)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAR247799
SAR247799 repeated doses once daily in the morning under fasted condition for 28 days according to a sequential dose design
Intervention: SAR247799 (Drug)
SAR247799
SAR247799 repeated doses once daily in the morning under fasted condition for 28 days according to a sequential dose design
Intervention: Acetylcholine (Drug)
Placebo
Identical matching placebo for SAR247799 and for sildenafil once daily in the morning under fasted condition for 28 days
Intervention: Placebo (Drug)
Placebo
Identical matching placebo for SAR247799 and for sildenafil once daily in the morning under fasted condition for 28 days
Intervention: Acetylcholine (Drug)
Sildenafil
Sildenafil once daily in the morning under fasted condition for 28 days
Intervention: Sildenafil (Drug)
Sildenafil
Sildenafil once daily in the morning under fasted condition for 28 days
Intervention: Acetylcholine (Drug)
Outcomes
Primary Outcomes
Change in Flow Mediated Dilation (FMD)
Time Frame: Baseline to Days 14, 21, 28, 35, and 42
Absolute change from baseline in the % FMD index of the brachial artery
Secondary Outcomes
- Microvascular reactivity(Baseline to Days 14, 21, 28, 35, and 42)
- Assessment of pharmacokinetic (PK) parameter: Cmax(Days 1, 2, 3, 7, and 14)
- Assessment of PK parameter: Ctrough(Days 1, 2, 3, 7, and 14)
- Number of adverse events(Up to Day 42)
- Assessment of PK parameter: tmax(Days 1, 2, 3, 7, and 14)
- Assessment of PK parameter: AUC0-24(Days 1, 2, 3, 7, and 14)