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ClinicalTrials.gov public records Last synced Oct 1, 2026, 10:21 PM EDT

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Showing 25–40 of 40 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: sotagliflozin Clear all
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 7, 2026 · Synced Oct 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 25, 2021 · Synced Oct 1, 2026, 10:21 PM 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 12, 2020 · Synced Oct 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM EDT
Terminated Phase 3 Interventional Results available

Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk

NCT03315143
View directory record Official record
Conditions
Heart Failure, Type 2 Diabetes Mellitus, Chronic Kidney Diseases
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
10,584 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
119
States / cities
Birmingham, Alabama • Sheffield, Alabama • Mesa, Arizona + 97 more
Source: ClinicalTrials.gov public record
Updated Oct 28, 2022 · Synced Oct 1, 2026, 10:21 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Sotagliflozin Bioequivalence Study

NCT03211195
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
76 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Oct 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM 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 1, 2026, 10:21 PM EDT