Inpefa (sotagliflozin) / Lexicon Pharma |
| 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 |
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| Completed | 2 | 36 | US | LX4211 Low Dose, LX4211 High Dose, Placebo | Lexicon Pharmaceuticals | Type 2 Diabetes Mellitus | 12/09 | | | |
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NCT01376557: Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin |
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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 | | |
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NCT01742208: Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus |
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| Completed | 2 | 36 | US | Sotagliflozin, LX4211, Placebo | Lexicon Pharmaceuticals, Sanofi | Type 1 Diabetes Mellitus | 01/14 | 01/14 | | |
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NCT02383940: Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C |
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| 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 |
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| 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 |
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| 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 |
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| Terminated | 2 | 32 | Europe, Canada, US | Sotagliflozin, SAR439954, Placebo | Lexicon Pharmaceuticals, Sanofi | Cardiac Failure Aggravated | 08/19 | 08/19 | | |
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| Recruiting | 2 | 50 | US | eGFR reporting | Martina McGrath, MD | Kidney Transplant | 07/23 | 11/23 | | |
| 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 |
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| 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 |
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| 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 | | |