Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03462017 | Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 54 | — | — | Mar 7, 2018 | Dec 22, 2018 | Apr 25, 2022 | 2 | Germany |
Absolute change from baseline in the % FMD index of the brachial artery
| Arm | Type | Description |
|---|---|---|
| SAR247799 | EXPERIMENTAL | SAR247799 repeated doses once daily in the morning under fasted condition for 28 days according to a sequential dose design |
| Placebo | PLACEBO_COMPARATOR | Identical matching placebo for SAR247799 and for sildenafil once daily in the morning under fasted condition for 28 days |
| Sildenafil | ACTIVE_COMPARATOR | Sildenafil once daily in the morning under fasted condition for 28 days |
| Name | Type | Description |
|---|---|---|
| SAR247799 | DRUG | Pharmaceutical form:Capsule Route of administration: Oral |
| Placebo | DRUG | Pharmaceutical form:Capsule Route of administration: Oral |
| Sildenafil | DRUG | Pharmaceutical form:Encapsulated tablet Route of administration: Oral |
| Acetylcholine | DRUG | Pharmaceutical form:Solution Route of administration: Transdermal |
Inclusion criteria : * Male and female stable Type 2 diabetes mellitus (T2DM) patients. * Body Mass Index between 18 and 35 kg/m\^2. * Stable T2DM patients, but otherwise healthy as assessed by a clinical and laboratory assessments and detailed medical history. * Diagnosis of T2DM for at least 6 mo...