Sotagliflozin Clinical Trials (2026): 52 Studies for Type 2 Diabetes Mellitus & Type 1 Diabetes Mellitus
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
52 Sotagliflozin clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 22 indications (including Type 2 Diabetes Mellitus & Type 1 Diabetes Mellitus) and 24,975 total planned enrollment. 20 Phase 3 Sotagliflozin trials and 11 Phase 2, 3 Phase 4 are listed. 15 Sotagliflozin clinical trials are actively recruiting at 50 U.S. sites across 24 states. Most recent activity: NCT07594145 (Dec 2031).
Where to Participate: All Sotagliflozin Trial Sites in the U.S. (50 sites across 24 states)
Every actively recruiting Sotagliflozintrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AZ | Lexicon Investigational Site (4041) | Phoenix85054 | NCT06481891 | Map |
| AZ | Lexicon Investigational Site (4037) | Scottsdale85260 | NCT06481891 | Map |
| CA | UC San Diego Altman Clinical & Translational Research Institute | La Jolla92037 | NCT05696366 | Map |
| CA | Lexicon Investigational Site (4012) | Los Angeles90048 | NCT06481891 | Map |
| CA | Lexicon Investigational Site (4035) | Pomona91767 | NCT06481891 | Map |
| CA | Lexicon Investigational Site (4044) | San Francisco94143 | NCT06481891 | Map |
| CA | Stanford University Medical Center | Stanford94305 | NCT06217302 | Map |
| CO | Barbara Davis Center / University of Colorado Denver | Aurora80045 | NCT06217302 | Map |
| FL | Lexicon Investigational Site (4046) | Jacksonville32224 | NCT06481891 | Map |
| FL | AdventHealth | Orlando32803 | NCT06217302 | Map |
| FL | Lexicon Investigational Site (4034) | Orlando32804 | NCT06481891 | Map |
| GA | Lexicon Investigational Site (4018) | Atlanta30322 | NCT06481891 | Map |
| IL | Northwestern University Feinberg School of Medicine | Chicago60611 | NCT06217302 | Map |
| IL | Lexicon Investigational Site (4033) | Evanston60208 | NCT06481891 | Map |
| IN | Lexicon Investigational Site (4036) | Merrillville46410 | NCT06481891 | Map |
| MD | Lexicon Investigational Site (4021) | Baltimore21218 | NCT06481891 | Map |
| MA | Joslin Diabetes Center | Boston02215 | NCT06217302 | Map |
| MA | Lexicon Investigational Site (4016) | Boston02115 | NCT06481891 | Map |
| MA | Lexicon Investigational Site (4042) | Boston02118 | NCT06481891 | Map |
| MI | Lexicon Investigational Site (4028) | Ann Arbor48109 | NCT06481891 | Map |
| MI | University of Michigan | Ann Arbor48109 | NCT06933056 | Map |
| MI | Lexicon Investigational Site (4038) | Grand Rapids49525 | NCT06481891 | Map |
| MN | Lexicon Investigational Site (4027) | Rochester55905 | NCT06481891 | Map |
| MO | Lexicon Investigational Site (4013) | St Louis63110 | NCT06481891 | Map |
| MO | Washington University | St Louis63110 | NCT06217302 | Map |
| NJ | Lexicon Investigational Site (4029) | Morristown07960 | NCT06481891 | Map |
| NY | Lexicon Investigational Site (4039) | Manhasset11030 | NCT06481891 | Map |
| NY | Lexicon Investigational Site (4043) | New York10016 | NCT06481891 | Map |
| NY | SUNY Upstate Medical University | Syracuse13210 | NCT06217302 | Map |
| NY | Albert Einstein College of Medicine / Montefiore Medical Center | The Bronx10461 | NCT06217302 | Map |
| NC | Lexicon Investigational Site (4026) | Morrisville27560 | NCT06481891 | Map |
| OH | Lexicon Investigational Site (4031) | Cincinnati45219 | NCT06481891 | Map |
| OH | Cleveland Clinic Foundation | Cleveland44195 | NCT06217302 | Map |
| OH | Lexicon Investigational Site (4017) | Cleveland44195 | NCT06481891 | Map |
| OK | Lexicon Investigational Site (4024) | Tulsa74104 | NCT06481891 | Map |
| OR | Lexicon Investigational Site (4015) | Portland97239 | NCT06481891 | Map |
| OR | Oregon Health and Science University | Portland97239 | NCT06217302 | Map |
| PA | Lexicon Investigational Site (4011) | Philadelphia19104 | NCT06481891 | Map |
| PA | University of Pennsylvania | Philadelphia19104 | NCT06433050 | Map |
| PA | University of Pennsylvania | Philadelphia19104 | NCT06510894 | Map |
| TN | Lexicon Investigational Site (4019) | Germantown38138 | NCT06481891 | Map |
| TX | University of Texas Southwestern | Dallas75390 | NCT06217302 | Map |
| TX | Lexicon Investigational Stie (4014) | Houston77030 | NCT06481891 | Map |
| VA | Lexicon Investigational Site (4032) | Charlottesville22908 | NCT06481891 | Map |
| WA | Lexicon Investigational Site (4010) | Seattle98195 | NCT06481891 | Map |
| WA | Lexicon Investigational Site (4045) | Seattle98101 | NCT06481891 | Map |
| WA | University of Washington | Seattle98105 | NCT06217302 | Map |
| WA | Providence Sacred Heart Medical Center | Spokane99204 | NCT06217302 | Map |
| WI | Lexicon Investigational Site (4022) | Marshfield54449 | NCT06481891 | Map |
| WI | Lexicon Investigational Site (4040) | Milwaukee53215 | NCT06481891 | Map |
Sotagliflozin clinical trials at a glance: phase × recruitment status
| Phase | recruiting | completed | terminated | not yet recruiting | unknown | Total |
|---|---|---|---|---|---|---|
| Early P1 | 2 | 2 | ||||
| P1 | 13 | 1 | 14 | |||
| P1/P2 | 1 | 1 | ||||
| P2 | 1 | 4 | 1 | 5 | 11 | |
| P3 | 3 | 11 | 5 | 1 | 20 | |
| P4 | 2 | 1 | 3 | |||
| N/A | 1 | 1 |
Recruiting Sotagliflozin clinical trials (15)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07594145 | Precision T1D Platform - New Therapies for Cardio-Renal Complications | P2 | Type 1 Diabetes | 57 | Sep 2026 |
| NCT07211802 | CKM For Safe Use of SGLT2i in Type 1 Diabetes | P3 | Type 1 Diabetes (T1D) | 52 | Jul 2026 |
| NCT07421518 | KARMAKetone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors | P2 | Type 1 Diabetes | 75 | Jun 2026 |
| NCT07572175 | SPARTACUSSotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity | P2 | Anthracycline-induced Cardiotoxicity | 60 | Jul 2026 |
| NCT06082063 | Steno1Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes | P3 | Cardiovascular Diseases | 2,000 | Jul 2024 |
| NCT06217302 | SUGARNSALTSotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease | P3 | Diabetic Nephropathies | 150 | Oct 2024 |
| NCT07547878 | RAPID-CKDRapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) | P4 | Chronic Kidney Disease | 64 | Apr 2026 |
| NCT07325201 | Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring | P2 | Type 1 Diabetes Mellitus | 80 | Jun 2026 |
| NCT05696366 | SOTACombination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes | P1/P2 | Type 1 Diabetes | 24 | Sep 2024 |
| NCT06510894 | Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression | — | Cardiac Sarcoidosis | 40 | Nov 2024 |
| NCT06435156 | SOPHISTSotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes | P2 | Type 1 Diabetes | 320 | Jan 2025 |
| NCT06433050 | SOTA-CROSS HCMSodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy | Early P1 | Hypertrophic Cardiomyopathy Without Obstruction | 26 | Dec 2024 |
| NCT06147232 | PLUTOPrevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia | P2 | Nephropathy | 69 | Feb 2025 |
| NCT06933056 | Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs | Early P1 | Platelet Function and Reactivity Tests | 20 | Sep 2025 |
| NCT06481891 | SONATA-HCMA Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy | P3 | Obstructive Cardiomyopathy, Hypertrophic | 500 | Sep 2024 |
Sotagliflozin clinical trials by indication
Type 2 Diabetes Mellitus (16)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03386344 | SOTA-BONE | P3 | terminated | Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
| NCT03761134 | — | P3 | terminated | Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea |
| NCT03760965 | — | P3 | terminated | Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise |
| NCT03242018 | SOTA-CKD4 | P3 | completed | 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 |
| NCT03242252 | SOTA-CKD3 | P3 | completed | 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 |
| NCT03285594 | SOTA-INS | P3 | completed | 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 |
| NCT03332771 | SOTA-GLIM | P3 | completed | Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy |
| NCT02926937 | — | P3 | completed | Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy |
| + 8 more, see All trials below. | ||||
Type 1 Diabetes Mellitus (7)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07325201 | — | P2 | not yet recruiting | Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring |
| NCT03310944 | — | P1 | completed | Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects |
| NCT02421510 | inTandem2 | P3 | completed | 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 | inTandem1 | P3 | completed | 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 |
| NCT02383940 | — | P2 | completed | Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C |
| NCT02459899 | inTandem4 | P2 | completed | Dose-ranging Study in Patients With Type 1 Diabetes Mellitus |
| NCT01742208 | LX4211 | P2 | completed | Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus |
Diabetes Mellitus (6)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03909451 | — | P1 | completed | Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects |
| NCT03462069 | — | P2 | completed | Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension |
| NCT03414723 | — | P1 | completed | A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril |
| NCT03174548 | — | P1 | completed | A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects |
| NCT03063580 | — | P1 | completed | Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin |
| NCT03070678 | — | P1 | completed | Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects |
Type 1 Diabetes (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07594145 | — | P2 | not yet recruiting | Precision T1D Platform - New Therapies for Cardio-Renal Complications |
| NCT07421518 | KARMA | P2 | not yet recruiting | Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors |
| NCT05696366 | SOTA | P1/P2 | recruiting | Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes |
| NCT06435156 | SOPHIST | P2 | recruiting | Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes |
Heart Failure (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03315143 | SCORED | P3 | terminated | Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk |
| NCT03521934 | — | P3 | terminated | Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) |
Anthracycline-induced Cardiotoxicity (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07572175 | SPARTACUS | P2 | not yet recruiting | Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity |
Type 1 Diabetes (T1D) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07211802 | — | P3 | not yet recruiting | CKM For Safe Use of SGLT2i in Type 1 Diabetes |
Chronic Kidney Disease (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07547878 | RAPID-CKD | P4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
Platelet Function and Reactivity Tests (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06933056 | — | Early P1 | recruiting | Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs |
Nephropathy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06147232 | PLUTO | P2 | not yet recruiting | Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia |
Thrombosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06618976 | SOTATHROMBUS | P4 | completed | Antithrombotic Activities of Sotagliflozin vs. Empagliflozin |
Hypertrophic Cardiomyopathy Without Obstruction (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06433050 | SOTA-CROSS HCM | Early P1 | recruiting | Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy |
Cardiac Sarcoidosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06510894 | — | N/A | recruiting | Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression |
Diabetic Nephropathies (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06217302 | SUGARNSALT | P3 | recruiting | Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease |
Obstructive Cardiomyopathy, Hypertrophic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06481891 | SONATA-HCM | P3 | recruiting | A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy |
Cardiovascular Diseases (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06082063 | Steno1 | P3 | recruiting | Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes |
Heart Failure With Preserved Ejection Fraction (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05562063 | — | P4 | completed | Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients |
Cardiac Failure Aggravated (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03292653 | — | P2 | terminated | Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure |
Renal Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02647918 | — | P1 | completed | Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function |
Type 1 Diabetes Mellitus (T1DM) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02531035 | inTandem3 | P3 | completed | 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 |
Healthy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02494609 | — | P1 | unknown | Oral Contraceptive DDI Study |
Hepatic Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT02471274 | — | P1 | completed | PK Study of Sotagliflozin in Subjects With Hepatic Impairment |
Sotagliflozin pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| RAPID-CKD | NCT07547878 | P4 | not yet recruiting | Chronic Kidney Disease | 64 | PMID 28597606 |
| SOTATHROMBUS | NCT06618976 | P4 | completed | Thrombosis | 17 | PMID 40748666 |
| Steno1 | NCT06082063 | P3 | recruiting | Cardiovascular Diseases | 2,000 | PMID 39078403 |
| SUGARNSALT | NCT06217302 | P3 | recruiting | Diabetic Nephropathies | 150 | PMID 39918875 |
| SONATA-HCM | NCT06481891 | P3 | recruiting | Obstructive Cardiomyopathy, Hypertrophic | 500 | — |
| SCORED | NCT03315143 | P3 | terminated | Heart Failure | 10,584 | PMID 38277468 |
| SOTA-BONE | NCT03386344 | P3 | terminated | Type 2 Diabetes Mellitus | 376 | — |
| SOTA-CKD4 | NCT03242018 | P3 | completed | Type 2 Diabetes Mellitus | 277 | PMID 34338408 |
| SOTA-CKD3 | NCT03242252 | P3 | completed | Type 2 Diabetes Mellitus | 787 | PMID 36782093 |
| SOTA-INS | NCT03285594 | P3 | completed | Type 2 Diabetes Mellitus | 571 | — |
| SOTA-GLIM | NCT03332771 | P3 | completed | Type 2 Diabetes Mellitus | 954 | — |
| SOTA-EMPA | NCT03351478 | P3 | completed | Type 2 Diabetes Mellitus | 770 | — |
| inTandem2 | NCT02421510 | P3 | completed | Type 1 Diabetes Mellitus | 782 | PMID 32928957 |
| inTandem3 | NCT02531035 | P3 | completed | Type 1 Diabetes Mellitus (T1DM) | 1,405 | PMID 28899222 |
| inTandem1 | NCT02384941 | P3 | completed | Type 1 Diabetes Mellitus | 793 | PMID 30833371 |
| KARMA | NCT07421518 | P2 | not yet recruiting | Type 1 Diabetes | 75 | — |
| SPARTACUS | NCT07572175 | P2 | not yet recruiting | Anthracycline-induced Cardiotoxicity | 60 | — |
| SOPHIST | NCT06435156 | P2 | recruiting | Type 1 Diabetes | 320 | — |
| PLUTO | NCT06147232 | P2 | not yet recruiting | Nephropathy | 69 | — |
| inTandem4 | NCT02459899 | P2 | completed | Type 1 Diabetes Mellitus | 141 | PMID 31264767 |
| LX4211 | NCT01742208 | P2 | completed | Type 1 Diabetes Mellitus | 36 | PMID 26049551 |
Terminated and withdrawn Sotagliflozin trials (6)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT03315143terminatedEffect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
- NCT03521934terminatedEffect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
- NCT03386344terminatedEfficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
- NCT03761134terminatedEfficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea
- NCT03760965terminatedEfficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
- NCT03292653terminatedSafety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
All Sotagliflozin trials (52)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07594145 | Precision T1D Platform - New Therapies for Cardio-Renal Complications | P2 | not yet recruiting | 57 | Oregon Health and Science University | Sep 2026 | |
| NCT07211802 | CKM For Safe Use of SGLT2i in Type 1 Diabetes | P3 | not yet recruiting | 52 | University of California, San Diego | Jul 2026 | |
| NCT07421518 | KARMA | Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors | P2 | not yet recruiting | 75 | AdventHealth Translational Research Institute | Jun 2026 |
| NCT07572175 | SPARTACUS | Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity | P2 | not yet recruiting | 60 | Icahn School of Medicine at Mount Sinai | Jul 2026 |
| NCT06082063 | Steno1 | Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes | P3 | recruiting | 2,000 | Steno Diabetes Center Copenhagen | Jul 2024 |
| NCT06217302 | SUGARNSALT | Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease | P3 | recruiting | 150 | Alessandro Doria | Oct 2024 |
| NCT07547878 | RAPID-CKD | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) | P4 | not yet recruiting | 64 | Baylor Research Institute | Apr 2026 |
| NCT07325201 | Reducing Risk of Diabetic Ketoacidosis in Type 1 Diabetes and Kidney Disease Using Continuous Ketone Monitoring | P2 | not yet recruiting | 80 | HealthPartners Institute | Jun 2026 | |
| NCT05696366 | SOTA | Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes | P1/P2 | recruiting | 24 | University of California, San Diego | Sep 2024 |
| NCT06510894 | Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression | — | recruiting | 40 | University of Pennsylvania | Nov 2024 | |
| NCT06435156 | SOPHIST | Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes | P2 | recruiting | 320 | University of Dundee | Jan 2025 |
| NCT06433050 | SOTA-CROSS HCM | Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy | Early P1 | recruiting | 26 | University of Pennsylvania | Dec 2024 |
| NCT06147232 | PLUTO | Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia | P2 | not yet recruiting | 69 | Steno Diabetes Center Copenhagen | Feb 2025 |
| NCT06933056 | Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs | Early P1 | recruiting | 20 | University of Michigan | Sep 2025 | |
| NCT06481891 | SONATA-HCM | A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy | P3 | recruiting | 500 | Lexicon Pharmaceuticals | Sep 2024 |
| NCT06618976 | SOTATHROMBUS | Antithrombotic Activities of Sotagliflozin vs. Empagliflozin | P4 | completed | 17 | Icahn School of Medicine at Mount Sinai | Feb 2025 |
| NCT05562063 | Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients | P4 | completed | 88 | Juan Badimon | Oct 2022 | |
| NCT03315143 | SCORED | Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk | P3 | terminated | 10,584 | Lexicon Pharmaceuticals | Dec 2017 |
| NCT03521934 | Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) | P3 | terminated | 1,222 | Lexicon Pharmaceuticals | Jun 2018 | |
| NCT03386344 | SOTA-BONE | Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control | P3 | terminated | 376 | Lexicon Pharmaceuticals | Feb 2018 |
| 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 | P3 | terminated | 377 | Sanofi | Nov 2018 | |
| NCT03760965 | Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise | P3 | terminated | 276 | Sanofi | Nov 2018 | |
| NCT03242018 | SOTA-CKD4 | 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 | P3 | completed | 277 | Lexicon Pharmaceuticals | Aug 2017 |
| NCT03242252 | SOTA-CKD3 | 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 | P3 | completed | 787 | Lexicon Pharmaceuticals | Aug 2017 |
| NCT03285594 | SOTA-INS | 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 | P3 | completed | 571 | Lexicon Pharmaceuticals | Sep 2017 |
| NCT03332771 | SOTA-GLIM | Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy | P3 | completed | 954 | Lexicon Pharmaceuticals | Dec 2017 |
| NCT03909451 | Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects | P1 | completed | 24 | Sanofi | Apr 2019 | |
| NCT03292653 | Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure | P2 | terminated | 32 | Lexicon Pharmaceuticals | Dec 2017 | |
| NCT02926937 | Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy | P3 | completed | 399 | Lexicon Pharmaceuticals | Nov 2016 | |
| NCT03351478 | SOTA-EMPA | 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 | P3 | completed | 770 | Lexicon Pharmaceuticals | Nov 2017 |
| NCT03066830 | Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin | P3 | completed | 507 | Lexicon Pharmaceuticals | Feb 2017 | |
| NCT03776227 | A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions | P1 | completed | 66 | Sanofi | Jan 2019 | |
| NCT03462069 | Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension | P2 | completed | 41 | Sanofi | Mar 2018 | |
| NCT03802487 | Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects | P1 | completed | 6 | Sanofi | Jan 2019 | |
| NCT02926950 | Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin | P3 | completed | 518 | Lexicon Pharmaceuticals | Nov 2016 | |
| NCT03414723 | A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril | P1 | completed | 16 | Sanofi | Jan 2018 | |
| NCT03387657 | A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide | P1 | completed | 16 | Sanofi | Jan 2018 | |
| NCT03310944 | Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects | P1 | completed | 12 | Sanofi | Oct 2017 | |
| NCT02647918 | Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function | P1 | completed | 50 | Lexicon Pharmaceuticals | Dec 2015 | |
| NCT03174548 | A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects | P1 | completed | 14 | Sanofi | Jun 2017 | |
| NCT03211195 | Sotagliflozin Bioequivalence Study | P1 | completed | 76 | Sanofi | Jun 2017 | |
| NCT02421510 | inTandem2 | 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 | P3 | completed | 782 | Lexicon Pharmaceuticals | May 2015 |
| NCT03063580 | Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin | P1 | completed | 16 | Sanofi | Feb 2017 | |
| NCT02531035 | inTandem3 | 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 | P3 | completed | 1,405 | Lexicon Pharmaceuticals | Sep 2015 |
| NCT03070678 | Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects | P1 | completed | 16 | Sanofi | Mar 2017 | |
| NCT02384941 | inTandem1 | 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 | P3 | completed | 793 | Lexicon Pharmaceuticals | Mar 2015 |
| NCT02940379 | A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol | P1 | completed | 24 | Sanofi | Oct 2016 | |
| NCT02383940 | Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C | P2 | completed | 87 | Lexicon Pharmaceuticals | Apr 2015 | |
| NCT02459899 | inTandem4 | Dose-ranging Study in Patients With Type 1 Diabetes Mellitus | P2 | completed | 141 | Lexicon Pharmaceuticals | Jul 2015 |
| NCT02494609 | Oral Contraceptive DDI Study | P1 | unknown | 30 | Lexicon Pharmaceuticals | Jul 2015 | |
| NCT02471274 | PK Study of Sotagliflozin in Subjects With Hepatic Impairment | P1 | completed | 32 | Lexicon Pharmaceuticals | Jun 2015 | |
| NCT01742208 | LX4211 | Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus | P2 | completed | 36 | Lexicon Pharmaceuticals | Feb 2013 |
Sotagliflozin clinical trials: frequently asked questions
- How many Sotagliflozin clinical trials are there?
- 52 Sotagliflozin clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 8 are actively recruiting participants. 30 are marked completed.
- Are Sotagliflozin clinical trials recruiting in 2026?
- Yes — 8 Sotagliflozin trials are actively recruiting in 2026, with 50 U.S. sites across 24 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Sotagliflozin being studied for?
- Sotagliflozin is being studied for Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Diabetes Mellitus, Heart Failure, Type 1 Diabetes and 39 more. The trials are grouped by indication on this page.
- What phase is Sotagliflozin in?
- Sotagliflozin clinical trials span 3 Phase 4, 20 Phase 3, 11 Phase 2, 14 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Sotagliflozin clinical trials?
- The lead sponsor across the most Sotagliflozin trials is Lexicon Pharmaceuticals, with 13 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Sotagliflozinas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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Related pages on Hipa.ai: