About this data
Pipeline and clinical trial information here comes primarily from ClinicalTrials.gov. A listing on ClinicalTrials.gov means a study has been registered — not that a treatment is proven safe, effective, or FDA-approved. Investigational treatments may never be approved. Who can join a trial is decided only by that trial's own study team.
Sotagliflozin
- Company
- Baylor Research Institute
- Mechanism
- Mechanism not yet reported
- Route
- Route not yet reported
- Recruiting trials
- 7 recruiting
Efficacy results: Not yet reported
7 recruiting studies currently listed on ClinicalTrials.gov.
Data source: ClinicalTrials.gov · trial data as of Oct 14, 2026
Find a Clinical Trial Near Me
See recruiting studies for Sotagliflozin and check eligibility with the study team.
Trial details
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Recruiting NCT NCT06082063
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Not yet reported Steno Diabetes Center Copenhagen 2000 participants Est. completion 2029-07-01 2 sitesCardiovascular diseaseHeart failure Other conditions: Type 1 Diabetes, Kidney FailureView official trial listing → -
Recruiting NCT NCT06217302
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
Not yet reported Alessandro Doria 150 participants Est. completion 2029-05 19 sitesHeart failure Other conditions: Diabetic Nephropathies, Kidney Failure, Chronic, Diabetes Mellitus Type 1View official trial listing → -
Recruiting NCT NCT06433050
Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
Not yet reported University of Pennsylvania 26 participants Est. completion 2027-06 1 siteOther conditions: Hypertrophic Cardiomyopathy Without ObstructionView official trial listing → -
Recruiting NCT NCT06435156
Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
Not yet reported University of Dundee 320 participants Est. completion 2027-10-31 17 sites Stand-aloneHeart failure Other conditions: Type 1 DiabetesView official trial listing → -
Recruiting NCT NCT06510894
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
University of Pennsylvania 40 participants Est. completion 2027-12-31 1 siteOther conditions: Cardiac SarcoidosisView official trial listing → -
Recruiting NCT NCT06933056
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
Not yet reported University of Michigan 20 participants Est. completion 2026-09 1 site Stand-aloneOther conditions: Platelet Function and Reactivity TestsView official trial listing → -
Recruiting NCT NCT07270172
The MICRON Study - A Steno 1 Substudy
University of Aarhus 40 participants Est. completion 2028-12 5 sitesOther conditions: Type 1 Diabetes MellitusView official trial listing → -
Completed NCT NCT01742208
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
Not yet reported Lexicon Pharmaceuticals 36 participants Est. completion 2014-01 7 sites Stand-aloneOther conditions: Type 1 Diabetes MellitusView official trial listing → -
Completed NCT NCT02383940
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Not yet reported Lexicon Pharmaceuticals 87 participants Est. completion 2016-09 15 sites Stand-aloneOther conditions: Type 1 Diabetes MellitusView official trial listing → -
Completed NCT NCT02384941
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Not yet reported Lexicon Pharmaceuticals 793 participants Est. completion 2017-02 75 sites Stand-aloneOther conditions: Type 1 Diabetes MellitusView official trial listing → -
Completed NCT NCT02421510
Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Not yet reported Lexicon Pharmaceuticals 782 participants Est. completion 2017-06-23 96 sites Stand-aloneOther conditions: Type 1 Diabetes MellitusView official trial listing → -
Completed NCT NCT02459899
Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
Not yet reported Lexicon Pharmaceuticals 141 participants Est. completion 2016-08 17 sites Stand-aloneOther conditions: Type 1 Diabetes MellitusView official trial listing → -
Completed NCT NCT02471274
PK Study of Sotagliflozin in Subjects With Hepatic Impairment
Not yet reported Lexicon Pharmaceuticals 32 participants 4 sites Stand-aloneOther conditions: Hepatic Impairment, HealthyView official trial listing → -
Status unknown NCT NCT02494609
Oral Contraceptive DDI Study
Not yet reported Lexicon Pharmaceuticals 30 participants 2 sites Stand-aloneOther conditions: HealthyView official trial listing → -
Completed NCT NCT02531035
A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone
Not yet reported Lexicon Pharmaceuticals 1405 participants Est. completion 2017-04 135 sites Stand-aloneOther conditions: Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the BloodView official trial listing → -
Completed NCT NCT02647918
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
Not yet reported Lexicon Pharmaceuticals 50 participants Est. completion 2017-09 4 sites Stand-aloneOther conditions: Renal Impairment, HealthyView official trial listing → -
Completed NCT NCT02926937
Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy
Not yet reported Lexicon Pharmaceuticals 399 participants Est. completion 2019-05-17 70 sites Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT02926950
Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin
Not yet reported Lexicon Pharmaceuticals 518 participants Est. completion 2019-03-22 93 sites Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT02940379
A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol
Not yet reported Sanofi 24 participants Est. completion 2016-12 1 site Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT03063580
Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin
Not yet reported Sanofi 16 participants Est. completion 2017-05-12 1 site Stand-aloneOther conditions: Diabetes MellitusView official trial listing → -
Completed NCT NCT03066830
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin
Not yet reported Lexicon Pharmaceuticals 507 participants Est. completion 2019-04-30 76 sites Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT03070678
Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects
Not yet reported Sanofi 16 participants Est. completion 2017-04-18 1 site Stand-aloneOther conditions: Diabetes MellitusView official trial listing → -
Completed NCT NCT03174548
A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects
Not yet reported Sanofi 14 participants Est. completion 2017-09-15 1 site Stand-aloneOther conditions: Diabetes MellitusView official trial listing → -
Completed NCT NCT03211195
Sotagliflozin Bioequivalence Study
Not yet reported Sanofi 76 participants Est. completion 2017-08-22 1 site Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT03242018
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Not yet reported Lexicon Pharmaceuticals 277 participants Est. completion 2019-12-11 106 sites Stand-aloneType 2 diabetesChronic kidney diseaseView official trial listing → -
Completed NCT NCT03242252
Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control
Not yet reported Lexicon Pharmaceuticals 787 participants Est. completion 2019-10-25 170 sites Stand-aloneType 2 diabetesChronic kidney diseaseView official trial listing → -
Completed NCT NCT03285594
Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents
Not yet reported Lexicon Pharmaceuticals 571 participants Est. completion 2019-09-27 106 sites Stand-aloneType 2 diabetesView official trial listing → -
Terminated NCT NCT03292653
Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
Not yet reported Lexicon Pharmaceuticals 32 participants Est. completion 2019-08-17 6 sites Stand-aloneOther conditions: Cardiac Failure AggravatedView official trial listing → -
Completed NCT NCT03310944
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
Not yet reported Sanofi 12 participants Est. completion 2017-12-08 1 site Stand-aloneType 2 diabetes Other conditions: Type 1 Diabetes MellitusView official trial listing → -
Terminated NCT NCT03315143
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Not yet reported Lexicon Pharmaceuticals 10584 participants Est. completion 2020-07-08 754 sites Stand-aloneHeart failureType 2 diabetesChronic kidney diseaseView official trial listing → -
Completed NCT NCT03332771
Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
Not yet reported Lexicon Pharmaceuticals 954 participants Est. completion 2019-09-06 142 sites Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT03351478
Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
Not yet reported Lexicon Pharmaceuticals 770 participants Est. completion 2019-05-16 160 sites Stand-aloneType 2 diabetesView official trial listing → -
Terminated NCT NCT03386344
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Not yet reported Lexicon Pharmaceuticals 376 participants Est. completion 2020-05-30 53 sites Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT03387657
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
Not yet reported Sanofi 16 participants Est. completion 2018-03-02 1 site Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT03414723
A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril
Not yet reported Sanofi 16 participants Est. completion 2018-03-10 1 site Stand-aloneOther conditions: Diabetes Mellitus, Healthy SubjectsView official trial listing → -
Completed NCT NCT03462069
Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension
Not yet reported Sanofi 41 participants Est. completion 2019-04-18 1 site Stand-aloneOther conditions: Diabetes MellitusView official trial listing → -
Terminated NCT NCT03521934
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Not yet reported Lexicon Pharmaceuticals 1222 participants Est. completion 2020-06-05 466 sites Stand-aloneHeart failureType 2 diabetesView official trial listing → -
Terminated NCT NCT03760965
Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
Not yet reported Sanofi 276 participants Est. completion 2020-04-24 29 sites Stand-aloneType 2 diabetesView official trial listing → -
Terminated NCT NCT03761134
Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea
Not yet reported Sanofi 377 participants Est. completion 2020-04-29 40 sites Stand-aloneType 2 diabetesView official trial listing → -
Completed NCT NCT03776227
A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
Not yet reported Sanofi 66 participants Est. completion 2019-04-22 1 site Stand-aloneType 2 diabetes Other conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT03802487
Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects
Not yet reported Sanofi 6 participants Est. completion 2019-03-28 1 site Stand-aloneType 2 diabetes Other conditions: Healthy SubjectsView official trial listing → -
Completed NCT NCT03909451
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
Not yet reported Sanofi 24 participants Est. completion 2019-08-19 1 site Stand-aloneOther conditions: Diabetes MellitusView official trial listing → -
Completed NCT NCT05405556
Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients
Not yet reported Martina McGrath, MD 40 participants Est. completion 2024-11-16 1 siteOther conditions: Kidney TransplantView official trial listing → -
Completed NCT NCT05562063
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Not yet reported Juan Badimon 88 participants Est. completion 2025-06-04 1 site Stand-aloneHeart failureView official trial listing → -
Active, not recruiting NCT NCT05696366
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
Not yet reported, Not yet reported University of California, San Diego 24 participants Est. completion 2028-01 1 siteOther conditions: Type 1 DiabetesView official trial listing → -
Not yet recruiting NCT NCT06147232
Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia
Not yet reported Steno Diabetes Center Copenhagen 69 participants Est. completion 2027-05 2 sites Stand-aloneOther conditions: Nephropathy, Diabetic Nephropathies, Diabetes Mellitus, Type 1, Albuminuria, Diabetic Complications Renal, Diabetic Complications Cardiovascular, HypoxiaView official trial listing → -
Active, not recruiting NCT NCT06481891
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Not yet reported Lexicon Pharmaceuticals 500 participants Est. completion 2027-02 108 sites Stand-aloneOther conditions: Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic CardiomyopathyView official trial listing → -
Completed NCT NCT06618976
Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
Not yet reported Icahn School of Medicine at Mount Sinai 17 participants Est. completion 2026-02-10 1 siteOther conditions: ThrombosisView official trial listing → -
Active, not recruiting NCT NCT07188545
Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
Ohio State University 23280000 participants Est. completion 2029-06-30 1 siteMetabolic syndromeView official trial listing → -
Not yet recruiting NCT NCT07211802
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Not yet reported University of California, San Diego 52 participants Est. completion 2030-12-31 1 site Stand-aloneOther conditions: Type 1 Diabetes (T1D)View official trial listing → -
Not yet recruiting NCT NCT07325201
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Not yet reported HealthPartners Institute 80 participants Est. completion 2030-02 1 site Stand-aloneChronic kidney disease Other conditions: Type 1 Diabetes Mellitus, Diabetic Ketoacidosis, KetonesView official trial listing → -
Not yet recruiting NCT NCT07421518
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
Not yet reported AdventHealth Translational Research Institute 75 participants Est. completion 2030-04 1 siteType 2 diabetes Other conditions: Type 1 DiabetesView official trial listing → -
Enrolling by invitation NCT NCT07547878
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Not yet reported Baylor Research Institute 64 participants Est. completion 2029-03-31 1 siteChronic kidney diseaseType 2 diabetesView official trial listing → -
Not yet recruiting NCT NCT07572175
Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity
Not yet reported Icahn School of Medicine at Mount Sinai 60 participants Est. completion 2029-10 1 siteOther conditions: Anthracycline-induced Cardiotoxicity, Lymphoma, Chemotherapy, CardiotoxicityView official trial listing → -
Not yet recruiting NCT NCT07594145
Precision T1D Platform - New Therapies for Cardio-Renal Complications
Not yet reported Oregon Health and Science University 57 participants Est. completion 2031-12-31 2 sites Stand-aloneHeart failureChronic kidney disease Other conditions: Type 1 Diabetes, Cardio-renal Vascular Function and FailureView official trial listing →
Efficacy history
Not yet reported.
Safety
Not yet reported.
Sources
Also known as: Sotagliflozin, INPEFA, SAR439954
Related On The Pen coverage
No related coverage yet.
This drug may be investigational and not yet approved for any use. Whether someone can join a clinical trial is determined only by that trial's own study team — On The Pen does not determine eligibility. Information here can change; always confirm current details on the official ClinicalTrials.gov listing or with the sponsor.