Clinical trials: sponsored by Sanofi
Type 2 Diabetes Mellitus
Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin
Primary Objective: To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the…
- Trial name
- ARTEMIS-DM (NCT03760991)
- Testing
- INSULIN GLARGINE (U300)
- Where
- 14 sites in Argentina, Colombia and 12 more
- Volunteers
- 372 people
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy
Primary Objective: To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes…
- Trial name
- EDITION AP (NCT02855684)
- Testing
- Insulin glargine (U300), Insulin glargine, Non-insulin antihyperglycemic drugs
- Where
- 54 sites in China, South Korea and 1 more
- Volunteers
- 604 people
- Sponsor
- Sanofi
Diabetes Mellitus, Type 2
Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan
Primary Objective: To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).
- Trial name
- LixiRam (NCT02941367)
- Testing
- Lixisenatide (AVE0010), Sulfonylurea, metformin
- Where
- 16 sites in India, Israel and 2 more
- Volunteers
- 184 people
- Sponsor
- Sanofi
Meningitis, Meningococcal Meningitis
Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation
The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation.
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02699840
- Testing
- Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Sleep Disorder (Healthy Volunteers)
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Primary Objective: To estimate the range of improvement of NOVANUIT® triple action on sleep quality global score. Secondary Objectives: To estimate the range of improvement of NOVANUIT® triple action on following parameters: time…
- Trial name
- NCT03514732
- Testing
- MELATONIN (MELATL07959)
- Where
- Poland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus, Healthy Subjects
A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
Primary Objective: To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects Secondary…
- Trial name
- NCT03776227
- Testing
- sotagliflozin (SAR439954)
- Where
- United States
- Volunteers
- 66 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
Type 2 Diabetes Mellitus
Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and…
- Trial name
- NCT03760965
- Testing
- sotagliflozin (SAR439954)
- Where
- 29 sites in China
- Volunteers
- 276 people
- 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 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
Dengue Fever, Dengue Haemorrhagic Fever
Association of Host Genetics With Vaccine Efficacy and Study of Immune Correlates of Risk From a Tetravalent Dengue Vaccine
Primary objectives: To assess how dengue vaccine efficacy varies across participant subgroups regarding polymorphism in human leukocyte antigen (HLA) alleles of interest.
- Trial name
- NCT02827162
- Where
- Thailand
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Gastroesophageal Reflux Disease
Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Primary Objective: Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets, in healthy adult…
- Trial name
- NCT03065816
- Testing
- Z0063, Gaviscon
- Where
- United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus
Study Comparing the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM)
Primary Objective: To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling.
- Trial name
- LixilanOne CAN (NCT03767543)
- Testing
- INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010
- Where
- 32 sites in Canada
- Volunteers
- 265 people
- Sponsor
- Sanofi
Diabetes Mellitus
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
Primary Objective: To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
- Trial name
- NCT03909451
- Testing
- Sotagliflozin (SAR439954)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus, Healthy Subjects
Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Primary Objective: To assess the absolute bioavailability of sotagliflozin via administration of an intravenous (IV) microdose of a 14C-sotagliflozin tracer on top of a single oral dose of unlabeled sotagliflozin without charcoal…
- Trial name
- NCT03802487
- Testing
- Sotagliflozin (SAR439954), 14C-microtracer, Charcoal
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Influenza
Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam
The primary objective of this study is to describe the safety of the Quadrivalent Influenza Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day…
- Trial name
- GQM10 (NCT03765437)
- Testing
- Quadrivalent Influenza Vaccine
- Where
- Vietnam
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Type 2 Diabetes Mellitus
Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive
Primary Objectives: To assess efficacy in terms of change from baseline in Hemoglobin A1c (HbA1c) at the end of study between the two drugs.
- Trial name
- ACADEMIC (NCT03794336)
- Testing
- Alogliptin, Acarbose, Metformin
- Where
- China
- Volunteers
- 1,293 people
- Sponsor
- Sanofi
Japanese Encephalitis
Postmarketing Surveillance Study for IMOJEV® in Republic of Korea
The purpose of the study is to perform the re-examination of IMOJEV® in routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.
- Trial name
- NCT02933710
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tetanus Immunisation (Healthy Volunteers), Diphtheria Immunisation (Healthy Volunteers)
A Study to Describe the Safety Profile and Compare the Immune Response of 4 Different Formulations of an Investigational Tdap Vaccine When Compared to Licensed Tdap Vaccine in Young Adults in Canada
The primary objectives of this study are: To describe the safety profile of each of the investigational vaccine formulations for all participants To describe the humoral and cell-mediated immune responses to all of the…
- Conditions
- Tetanus Immunisation (Healthy Volunteers), Diphtheria Immunisation (Healthy Volunteers), Pertussis Immunisation (Healthy Volunteers)
- Trial name
- NCT03958799
- Testing
- Investigational Tdap vaccine Formulation B, Investigational Tdap vaccine Formulation C, Investigational Tdap vaccine Formulation A
- Where
- 5 sites in Canada
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea
The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation.
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02864927
- Testing
- Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- South Korea
- Volunteers
- 1,311 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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