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Showing 1–24 of 40 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Sotagliflozin Clear all
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 11, 2020 · Synced Sep 2, 2026, 5:32 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 10, 2021 · Synced Sep 2, 2026, 5:32 AM EDT
Recruiting Early Phase 1 Interventional

Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy

NCT06433050
View directory record Official record
Conditions
Hypertrophic Cardiomyopathy Without Obstruction
Interventions
Sotagliflozin
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 10, 2026 · Synced Sep 2, 2026, 5:32 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 18, 2026 · Synced Sep 2, 2026, 5:32 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 29, 2026 · Synced Sep 2, 2026, 5:32 AM EDT
Not yet recruiting Phase 3 Interventional

CKM For Safe Use of SGLT2i in Type 1 Diabetes

NCT07211802
View directory record Official record
Conditions
Type 1 Diabetes (T1D)
Interventions
Sotagliflozin Low Dose, Sotagliflozin High Dose, Dual Continuous Glucose and Ketone Monitor
Drug · Device
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Oct 7, 2025 · Synced Sep 2, 2026, 5:32 AM EDT
Not yet recruiting Phase 4 Interventional

Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)

NCT07547878
View directory record Official record
Conditions
Chronic Kidney Disease, Type 2 Diabetes
Interventions
Finerenone, Semaglutide, Lotensin, Capoten, Enalapril, Monopril, Lisinopril, Univasc, Aceon, Accupril, Altace, Mavik, Edarbi, Atacand, Avapro, Cozaar, Benicar, Micardis, Diovan, Invokana, Farxiga, Jardiance, Ertugliflozin, Brenzavvy, Sotagliflozin
Drug
Lead sponsor
Baylor Research Institute
Other
Eligibility
18 Years to 84 Years
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Temple, Texas
Source: ClinicalTrials.gov public record
Updated May 7, 2026 · Synced Sep 2, 2026, 5:32 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 6, 2026 · Synced Sep 2, 2026, 5:32 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 11, 2020 · Synced Sep 2, 2026, 5:32 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 10, 2021 · Synced Sep 2, 2026, 5:32 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 10, 2021 · Synced Sep 2, 2026, 5:32 AM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression

NCT06510894
View directory record Official record
Conditions
Cardiac Sarcoidosis
Interventions
Sotagliflozin
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
Not listed
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 6, 2026 · Synced Sep 2, 2026, 5:32 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 24, 2022 · Synced Sep 2, 2026, 5:32 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

NCT03066830
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954), Placebo, Metformin, Sulfonylurea
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
507 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
28
States / cities
Litchfield Park, Arizona • Peoria, Arizona • Greenbrae, California + 25 more
Source: ClinicalTrials.gov public record
Updated May 10, 2021 · Synced Sep 2, 2026, 5:32 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 23, 2026 · Synced Sep 2, 2026, 5:32 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 24, 2021 · Synced Sep 2, 2026, 5:32 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03242252
View directory record Official record
Conditions
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
787 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
51
States / cities
Birmingham, Alabama • Guntersville, Alabama • Phoenix, Arizona + 42 more
Source: ClinicalTrials.gov public record
Updated Jun 24, 2021 · Synced Sep 2, 2026, 5:32 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 11, 2020 · Synced Sep 2, 2026, 5:32 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 23, 2026 · Synced Sep 2, 2026, 5:32 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 22, 2025 · Synced Sep 2, 2026, 5:32 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 4, 2025 · Synced Sep 2, 2026, 5:32 AM EDT
Active, not recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy

NCT06481891
View directory record Official record
Conditions
Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
33
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Los Angeles, California + 28 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 2, 2026, 5:32 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

NCT02647918
View directory record Official record
Conditions
Renal Impairment, Healthy
Interventions
Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
4
States / cities
Miami, Florida • Orlando, Florida • Minneapolis, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 25, 2019 · Synced Sep 2, 2026, 5:32 AM EDT
Completed Phase 2 Interventional Results available

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

NCT02383940
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 30 Years
Enrollment
87 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
15
States / cities
Tustin, California • Aurora, Colorado • New Haven, Connecticut + 12 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2020 · Synced Sep 2, 2026, 5:32 AM EDT