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ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:33 AM EDT

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Showing 1–24 of 40 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Sotagliflozin Clear all
Completed Phase 3 Interventional Results available

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

NCT02926937
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954), Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
399 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
56
States / cities
Tucson, Arizona • Anaheim, California • Canoga Park, California + 46 more
Source: ClinicalTrials.gov public record
Updated Jun 21, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03285594
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin, Insulin glargine (HOE901), Placebo, Oral Antidiabetes Drugs (OADs)
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
571 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
50
States / cities
Mesa, Arizona • Phoenix, Arizona • Huntington Park, California + 42 more
Source: ClinicalTrials.gov public record
Updated May 11, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03351478
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin, Empagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
770 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
53
States / cities
Birmingham, Alabama • Sheffield, Alabama • Hawaiian Gardens, California + 40 more
Source: ClinicalTrials.gov public record
Updated May 11, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

NCT03332771
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954), Glimepiride, Metformin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
954 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
115
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Anaheim, California + 101 more
Source: ClinicalTrials.gov public record
Updated May 11, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 2 Interventional Results available

Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

NCT02459899
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
17
States / cities
Concord, California • Ventura, California • Denver, Colorado + 14 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2020 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02384941
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
793 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
63
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Escondido, California + 55 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2020 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

NCT02940379
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
sotagliflozin (SAR439954), midazolam, metoprolol
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Knoxville, Tennessee
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Oct 17, 2026, 9:33 AM EDT
Terminated Phase 3 Interventional Results available

Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

NCT03386344
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
55 Years and older
Enrollment
376 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
14
States / cities
Escondido, California • Greenbrae, California • Walnut Creek, California + 11 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Not yet recruiting Phase 2 Interventional

Precision T1D Platform - New Therapies for Cardio-Renal Complications

NCT07594145
View directory record Official record
Conditions
Type 1 Diabetes, T1D Heart Failure, Cardio-renal Vascular Function and Failure, Diabetic Chronic Kidney Disease
Interventions
Finerenone, Sotagliflozin
Drug
Lead sponsor
Oregon Health and Science University
Other
Eligibility
18 Years to 75 Years
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
2
States / cities
Ann Arbor, Michigan • Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions

NCT03776227
View directory record Official record
Conditions
Type 2 Diabetes Mellitus, Healthy Subjects
Interventions
sotagliflozin (SAR439954)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
66 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 2 Interventional

Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients

NCT05405556
View directory record Official record
Conditions
Kidney Transplant
Interventions
eGFR reporting
Diagnostic Test
Lead sponsor
Martina McGrath, MD
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 5, 2025 · Synced Oct 17, 2026, 9:33 AM EDT
Recruiting Phase 3 Interventional

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

NCT06217302
View directory record Official record
Conditions
Diabetic Nephropathies, Kidney Failure, Chronic, Diabetes Mellitus Type 1, Heart Failure
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Alessandro Doria
Other
Eligibility
18 Years to 75 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
13
States / cities
Stanford, California • Aurora, Colorado • Orlando, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Mar 24, 2026 · Synced Oct 17, 2026, 9:33 AM EDT
Not yet recruiting Phase 2 Interventional Accepts healthy volunteers

Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors

NCT07421518
View directory record Official record
Conditions
Type 1 Diabetes, Type 2 Diabetes
Interventions
SGLT-2 inhibitor (Sotagliflozin), Insulin withdrawal test (IWT)
Drug · Other
Lead sponsor
AdventHealth Translational Research Institute
Other
Eligibility
18 Years to 40 Years
Enrollment
75 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2030
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Feb 19, 2026 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

NCT06618976
View directory record Official record
Conditions
Thrombosis
Interventions
Sotagliflozin, Empagliflozin
Drug
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

NCT01742208
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
7
States / cities
Aurora, Colorado • Atlanta, Georgia • Baton Rouge, Louisiana + 4 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2020 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

NCT02926950
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954), Placebo, Metformin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
518 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
67
States / cities
Birmingham, Alabama • Phoenix, Arizona • Canoga Park, California + 50 more
Source: ClinicalTrials.gov public record
Updated May 11, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

NCT03387657
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954), Hydrochlorothiazide
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Oct 17, 2026, 9:33 AM EDT
Not listed Phase 1 Interventional Accepts healthy volunteers

Oral Contraceptive DDI Study

NCT02494609
View directory record Official record
Conditions
Healthy
Interventions
sotagliflozin, oral contraceptive, oral contraceptive + sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
Started 2015
U.S. locations
2
States / cities
Evansville, Indiana • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 2, 2016 · Synced Oct 17, 2026, 9:33 AM EDT
Active, not recruiting No phase listed Observational

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)

NCT07188545
View directory record Official record
Conditions
Cardiovascular Kidney Metabolic Syndrome
Interventions
Intervention, Active Comparator
Drug
Lead sponsor
Ohio State University
Other
Eligibility
18 Years and older
Enrollment
23,280,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 23, 2025 · Synced Oct 17, 2026, 9:33 AM EDT
Not yet recruiting Phase 2 Interventional

Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity

NCT07572175
View directory record Official record
Conditions
Anthracycline-induced Cardiotoxicity, Lymphoma, Chemotherapy, Cardiotoxicity
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 7, 2026 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02531035
View directory record Official record
Conditions
Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
1,405 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
33
States / cities
Concord, California • Escondido, California • La Jolla, California + 30 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2020 · Synced Oct 17, 2026, 9:33 AM EDT
Terminated Phase 2 Interventional Results available

Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure

NCT03292653
View directory record Official record
Conditions
Cardiac Failure Aggravated
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
4
States / cities
La Jolla, California • New Haven, Connecticut • Rochester, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated May 11, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03242018
View directory record Official record
Conditions
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
277 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
34
States / cities
Guntersville, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 29 more
Source: ClinicalTrials.gov public record
Updated Jun 25, 2021 · Synced Oct 17, 2026, 9:33 AM EDT
Completed Phase 4 Interventional Results available

Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients

NCT05562063
View directory record Official record
Conditions
Heart Failure With Preserved Ejection Fraction
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Juan Badimon
Other
Eligibility
18 Years and older
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 24, 2026 · Synced Oct 17, 2026, 9:33 AM EDT