Inpefa (sotagliflozin) / Lexicon Pharma  >>  Phase 2
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12 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Inpefa (sotagliflozin) / Lexicon Pharma
inTandem4, NCT02459899: Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

Completed
2b
141
US
Placebo, Sotagliflozin
Lexicon Pharmaceuticals, Sanofi
Type 1 Diabetes Mellitus
08/16
08/16
NCT00962065: Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

Checkmark
Jan 2013 - Jan 2013: 
Checkmark P2 data
Jun 2012 - Jun 2012: P2 data
Checkmark P2a data
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Completed
2
36
US
LX4211 Low Dose, LX4211 High Dose, Placebo
Lexicon Pharmaceuticals
Type 2 Diabetes Mellitus
12/09
 
NCT01376557: Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark EASD 2013
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Completed
2
299
US
75 mg LX4211, 200 mg LX4211, 400 mg LX4211, Placebo
Lexicon Pharmaceuticals
Type 2 Diabetes Mellitus
05/12
05/12
NCT01742208: Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus

Checkmark POC data for type 1 diabetes mellitus
Apr 2014 - Apr 2014: POC data for type 1 diabetes mellitus
Checkmark Type 1 diabetes
Apr 2014 - Apr 2014: Type 1 diabetes
Completed
2
36
US
Sotagliflozin, LX4211, Placebo
Lexicon Pharmaceuticals, Sanofi
Type 1 Diabetes Mellitus
01/14
01/14
NCT02383940: Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

Completed
2
87
US
Sotagliflozin, LX4211, Placebo
Lexicon Pharmaceuticals, Juvenile Diabetes Research Foundation, Sanofi
Type 1 Diabetes Mellitus
09/16
09/16
2017-002309-36: Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients with Mild to Moderate Hypertension

Ongoing
2
40
Europe
Sotagliflozin, Jardiance, SAR439954, Film-coated tablet, Capsule, Jardiance
SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT, SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
Diabetes mellitus, Diabetes mellitus, Diseases [C] - Nutritional and Metabolic Diseases [C18]
 
 
NCT03462069 / 2017-002309-36: Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension

Completed
2
41
Europe
Sotagliflozin (SAR439954), Placebo, Empagliflozin, Jardiance®
Sanofi, SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
Diabetes Mellitus
04/19
04/19
NCT03292653 / 2017-002774-39: Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure

Hourglass Jan 2020 - Dec 2020 : From trial in worsening heart failure
Terminated
2
32
Europe, Canada, US
Sotagliflozin, SAR439954, Placebo
Lexicon Pharmaceuticals, Sanofi
Cardiac Failure Aggravated
08/19
08/19
START, NCT05405556: Sotagliflozin Safety and Tolerability Among Renal Transplant Recipients

Recruiting
2
50
US
eGFR reporting
Martina McGrath, MD
Kidney Transplant
07/23
11/23
SOPHIST, NCT06435156: Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes

Not yet recruiting
2
320
NA
Sotagliflozin, Placebo
University of Dundee, Lexicon Pharmaceuticals, Juvenile Diabetes Research Foundation
Type 1 Diabetes, Heart Failure
06/26
06/26
ASPIRE, NCT06072326: Ambrisentan Sotagliflozin and Prevention of Renal Injury; a Randomized Evaluation

Not yet recruiting
2
36
Europe, Canada, US
Sotagliflozin, Ambrisentan, Ambrisentan and Sotagliflozin
University Medical Center Groningen, Juvenile Diabetes Research Foundation, Lexicon Pharmaceuticals
Type 1 Diabetes Mellitus With Diabetic Nephropathy
03/25
03/25
SOTA, NCT05696366: Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

Not yet recruiting
1/2
22
NA
Sotagliflozin, Volagidemab
University of California, San Diego, Juvenile Diabetes Research Foundation
Type 1 Diabetes
01/26
01/26

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