Clinical trials: sponsored by 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 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
Diabetes Mellitus, Type 2
A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin
Primary Objective: To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change Secondary Objectives: To demonstrate superiority of Toujeo versus…
- Trial name
- REGAIN CONTROL (NCT02967211)
- Testing
- insulin glargine (U300), insulin glargine (U100), NPH insulin
- Where
- 118 sites in Brazil, Finland and 8 more
- Volunteers
- 609 people
- Sponsor
- Sanofi
Haemophilus Infections, Diphtheria
Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.
- Conditions
- Haemophilus Infections, Diphtheria, Tetanus, Polio
- Trial name
- NCT00855855
- Testing
- DTaP-IPV/Hib
- Where
- 59 sites in United States
- Volunteers
- 20,830 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Type1 Diabetes Mellitus
A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Primary Objective: To demonstrate bioequivalence between insulin glulisine given as 300 Units/mL test formulation and insulin glulisine 100 Units/mL reference formulation after a single subcutaneous (SC) dose.
- Trial name
- NCT02910518
- Testing
- Insulin glulisine (U300), Insulin glulisine, Insulin aspart
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Sanofi
Diabetes Mellitus, Type 2
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
Primary Objective: -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia…
- Trial name
- NCT02836704
- Testing
- INSULIN GLARGINE, metformin, acarbose
- Where
- China
- Volunteers
- 892 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol
Primary Objective: To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam.
- Trial name
- NCT02940379
- Testing
- sotagliflozin (SAR439954), midazolam, metoprolol
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 1 Diabetes
Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus
Primary Objectives: To demonstrate similarity in exposure of SAR341402 Mix 70/30 to NovoLog Mix 70/30 and NovoMix 30 (cohort 1).
- Trial name
- NCT03916601
- Testing
- SAR341402, Insulin Aspart
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- Sanofi
Influenza
Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India
The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India: Primary objective: To describe in each age group the immune…
- Trial name
- NCT02451358
- Testing
- Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative
- Where
- 8 sites in India
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rabies Virus
Immunogenicity and Safety of a Purified Vero Rabies Vaccine
This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.
- Trial name
- NCT03145766
- Testing
- VRVg 2, VRVg 1, Imovax Rabies
- Where
- 5 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Neoplasm Malignant
Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from…
- Trial name
- NCT01587040
- Testing
- SAR245408, SAR245409
- Where
- 21 sites in United States, Belgium and 2 more
- Volunteers
- 61 people
- Sponsor
- Sanofi
Hemophilia A
A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)
The primary purpose was to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.
- Trial name
- NCT03205163
- Testing
- Advate (Low Dose), Advate (High Dose), BIVV001 (Low Dose)
- Where
- 10 sites in United States, Japan
- Volunteers
- 16 people
- Sponsor
- Bioverativ, a Sanofi company
Meningitis, Meningococcal Infection
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers.
- Trial name
- NCT01890759
- Testing
- Meningococcal Diphtheria Toxoid Vaccine
- Where
- 8 sites in India, Russia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Stargardt's Disease
Phase I/IIA Study of SAR422459 in Participants With Stargardt's Macular Degeneration
Primary Objective: To assess the safety and tolerability of ascending doses of SAR422459 in participants with Stargardt's Macular Degeneration (SMD). Secondary Objective: To evaluate for possible biological activity of SAR422459.
- Trial name
- NCT01367444
- Testing
- SAR422459
- Where
- 5 sites in United States, France
- Volunteers
- 27 people
- Sponsor
- Sanofi
Glycogen Storage Disease Type II
Evaluate Efficacy and Safety in Chinese Patients With Infantile-Onset Pompe Disease With One Year Alglucosidase Alfa Treatment
Primary Objective: To evaluate effect of 52-week treatment with Alglucosidase Alfa in the extension of survival and improvement of cardiomyopathy measured by Left Ventricular Mass Index in Chinese patients with infantile-onset…
- Trial name
- APOLLO-IOPD (NCT03687333)
- Testing
- ALGLUCOSIDASE ALFA (MYOZYME)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Genzyme, a Sanofi Company
Osteoarthritis
Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee
Primary Objective: To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for relief of knee pain in patients with osteoarthritis (OA) of the knee.
- Trial name
- NCT02845271
- Testing
- GZ389988, acetaminophen or paracetamol, fixed combination of paracetamol + codeine
- Where
- 2 sites in Germany
- Volunteers
- 104 people
- Sponsor
- Genzyme, a Sanofi Company
Non-alcoholic Steatohepatitis, Type 2 Diabetes Mellitus
Assessment of the Safety and Effect of SAR425899 Versus Placebo for the Treatment of Non-alcoholic Fatty Liver Disease
Primary Objective: To evaluate the dose response relationship of SAR425899 compared to placebo on resolution of non-alcoholic steatohepatitis (NASH) with no worsening of fibrosis in diabetic and non-diabetic patients with…
- Trial name
- Restore (NCT03437720)
- Testing
- SAR425899
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
Primary Objective: To evaluate the effect of irbesartan/atorvastatin fixed-dose combination comparing to each irbesartan and atorvastatin on flow mediated dilation change in type 2 diabetic patients diagnosed with hyperlipidemia…
- Trial name
- NCT02842359
- Testing
- Irbesartan/atorvastatin fixed dose combination, Irbesartan SR47436, Atorvastatin
- Where
- South Korea
- Volunteers
- 11 people
- Sponsor
- Sanofi
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
Primary Objective: To assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in…
- Trial name
- NCT03310944
- Testing
- sotagliflozin (SAR439954)
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Sanofi
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