Clinical trials: sponsored by Sanofi
Diabetes Mellitus
Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects
Primary Objective: To assess the effect of multiple dose mefenamic acid on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects.
- Trial name
- NCT03070678
- Testing
- Sotagliflozin (SAR439954), Mefenamic acid
- Where
- France
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
End-stage Renal Disease
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
Primary Objective: To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney…
- Trial name
- START-DCD (NCT03099122)
- Testing
- Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus, Methylprednisolone
- Where
- China
- Volunteers
- 115 people
- Sponsor
- Sanofi
Coronary Artery Disease
An Open-label, Non-comparative Study to Document the Tolerability to Ramipril in Patients With at Least One High Risk for Developing a Major Cardiovascular Event
Primary Objective: To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator.
- Trial name
- HOPETips (NCT03099213)
- Testing
- RAMIPRIL HOE498
- Where
- Indonesia
- Volunteers
- 179 people
- Sponsor
- Sanofi
Whooping Cough, Pertussis
Observational Study Describing the Immune Profile Induced By Pertussis Vaccines
This is an observational study designed to describe the immune profile of toddlers and preschoolers with acellular priming after receiving a booster dose of pertussis vaccine.
- Trial name
- NCT03147898
- Where
- 2 sites in Mexico, Panama
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diabetes Mellitus
A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects
Primary Objective: To evaluate the effect of food on the single-dose pharmacokinetics of sotagliflozin relative to a fasted state in healthy adult male and female subjects.
- Trial name
- NCT03174548
- Testing
- Sotagliflozin (SAR439954)
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 1 Diabetes
A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
Primary Objective: To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®. Secondary Objective: To assess the safety and tolerability of SAR341402.
- Trial name
- NCT03202875
- Testing
- SAR341402, Insulin Aspart
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Sotagliflozin Bioequivalence Study
Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and…
- Trial name
- NCT03211195
- Testing
- Sotagliflozin (SAR439954)
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 1 Diabetes
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
Primary Objective: To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics. Secondary Objectives: To document the profile of Type 1 diabetes patients.
- Trial name
- SHINE (NCT03312478)
- Testing
- Blood draw for insulin auto-anti body tests*
- Where
- Pakistan
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Sanofi
Rhinitis Allergic
A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)
Primary Objective: To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective total nasal symptom score (rTNSS) (24 h) after…
- Trial name
- NASANIF (NCT03317015)
- Testing
- triamcinolone XRG5029, fluticasone
- Volunteers
- 260 people
- Sponsor
- Sanofi
Influenza, Flu
Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years
This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent…
- Trial name
- NCT03344029
- Testing
- SP Shz TIV, Hualan TIV
- Where
- China
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
A Clinical Study to Investigate if SAR425899 Binds to the Liver and Pancreas in Overweight to Obese Type 2 Diabetes Mellitus Patients
Primary Objectives: To assess in overweight to obese T2DM patients: The glucagon receptor occupancy of SAR425899 at two dose levels in the human liver with positron-emission tomography (PET) imaging using…
- Trial name
- NCT03350191
- Testing
- SAR425899, [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer), [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
- Where
- Sweden
- Volunteers
- 13 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy
Primary Objective: To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of…
- Trial name
- SWITCH (NCT03359837)
- Testing
- INSULIN GLARGINE (HOE901), Insulin Glulisine, Biphasic insulin aspart 30
- Where
- China
- Volunteers
- 384 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
Primary Objective: To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.
- Trial name
- NCT03376802
- Testing
- SAR425899
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.
- Trial name
- NCT03387657
- Testing
- Sotagliflozin (SAR439954), Hydrochlorothiazide
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type I Diabetes Mellitus
Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
Primary Objective: To evaluate the efficacy of switching treatment from twice-daily basal insulin to once-daily insulin glargine (U300) as part of basal bolus regime in terms of glycated hemoglobin improvement (reduction by at…
- Trial name
- TOP1 (NCT03406000)
- Testing
- INSULIN GLARGINE (U300)
- Where
- 11 sites in Brazil
- Volunteers
- 170 people
- Sponsor
- Sanofi
Diabetes Mellitus, Healthy Subjects
A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril
Primary Objective: To evaluate the effects of multiple-dose ramipril on the steady state pharmacokinetic (PK) parameters of sotagliflozin and its main metabolite (sotagliflozin-3-O-glucuronide) in healthy male and female…
- Trial name
- NCT03414723
- Testing
- Sotagliflozin (SAR439954), Ramipril
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period
Primary Objectives: Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation…
- Trial name
- NCT03414736
- Testing
- SAR425899
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus
Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients
Primary Objective: To assess the safety of SAR341402 and NovoLog® when used in external insulin pumps in terms of the number of patients with infusion set occlusions.
- Trial name
- NCT03436498
- Testing
- Insulin aspart SAR341402, Insulin aspart
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Sanofi
Microvascular Coronary Artery Disease
Pharmacodynamic Study to Assess the Effects of Repeated Dosing of SAR247799 on Endothelial Function in Patients With Type 2 Diabetes Mellitus
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).
- Trial name
- NCT03462017
- Testing
- SAR247799, Sildenafil, Acetylcholine
- Where
- 2 sites in Germany
- Volunteers
- 54 people
- Sponsor
- Sanofi
Diabetes Mellitus
Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension
Primary Objective: To compare the metabolic and gastrointestinal pharmacodynamic (PD) effects of an 8 weeks treatment with sotagliflozin once daily (QD) to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive…
- Trial name
- NCT03462069
- Testing
- Sotagliflozin (SAR439954), Empagliflozin
- Where
- Germany
- Volunteers
- 41 people
- Sponsor
- Sanofi