| Inpefa (sotagliflozin) / Lexicon Pharma |
NCT01916850: Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects |
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| Completed | 1b | 25 | US | LX4211 400 mg, LX4211 800 mg, LX4211 Placebo | Lexicon Pharmaceuticals | Healthy | 10/13 | | | |
NCT01188863: Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus |
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| Completed | 1 | 15 | US | 300 mg LX4211 (150 mg tablets), 300 mg LX4211 (50 mg tablets), 300 mg LX4211 (liquid) | Lexicon Pharmaceuticals | Type 2 Diabetes Mellitus | 10/10 | | | |
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NCT01292993: A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects |
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| Completed | 1 | 18 | US | 400 mg LX4211, 1000 mg metformin | Lexicon Pharmaceuticals | Type 2 Diabetes Mellitus | 03/11 | | | |
NCT01334242: A Study to Determine the Pharmacodynamics of LX4211 Relative to Meals in Healthy Subjects |
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| Completed | 1 | 14 | US | Schedule A, Schedule B, Schedule C, Schedule D, Schedule E | Lexicon Pharmaceuticals | Healthy | 04/11 | | | |
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NCT01441232: A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics |
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| Completed | 1 | 18 | US | LX4211, Januvia® | Lexicon Pharmaceuticals | Type 2 Diabetes Mellitus | 11/11 | | | |
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NCT01818232: Study to Determine the Absorption, Metabolism, and Excretion of [14C]LX4211 in Healthy Male Subjects |
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| Completed | 1 | 8 | US | [14C]-LX4211 | Lexicon Pharmaceuticals | Healthy | 05/13 | 05/13 | | |
NCT01555008: Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment |
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| Completed | 1 | 31 | US | LX4211, LX4211 Placebo | Lexicon Pharmaceuticals | Type 2 Diabetes Mellitus, Renal Impairment | 08/13 | | | |
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NCT01913002: Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy Subjects |
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| Completed | 1 | 63 | US | LX4211 800 mg, LX4211 2000 mg, moxifloxacin 400 mg, LX4211 Placebo | Lexicon Pharmaceuticals | Healthy | 10/13 | | | |
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NCT01916863: Study to Evaluate the Effect of Single Doses of LX4211 and Canagliflozin on Intestinal Glucose Absorption in Healthy Adult Subjects |
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| Completed | 1 | 25 | US | LX4211 400 mg, canagliflozin 300 mg, LX4211 Placebo | Lexicon Pharmaceuticals | Healthy Subjects | 10/13 | | | |
NCT02300363: DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin |
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| Completed | 1 | 24 | US | Treatment A (rosuvastatin), Treatment B (LX4211), Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly) | Lexicon Pharmaceuticals | Healthy | 11/14 | 11/14 | | |
NCT02300350: DDI Study With Multiple-dose LX4211 and Single Dose Digoxin |
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| Completed | 1 | 24 | US | Treatment A digoxin, Treatment B LX4211, Treatment C Digoxin + 400 mg LX4211 administered concomitantly | Lexicon Pharmaceuticals | Healthy | 12/14 | 12/14 | | |
NCT02373046: Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets |
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| Completed | 1 | 30 | US | LX4211 | Lexicon Pharmaceuticals | Healthy | 04/15 | | | |
| Unknown status | 1 | 30 | US | sotagliflozin, oral contraceptive, oral contraceptive + sotagliflozin | Lexicon Pharmaceuticals | Healthy | 11/15 | | | |
NCT02471274: PK Study of Sotagliflozin in Subjects With Hepatic Impairment |
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| Completed | 1 | 32 | US | sotagliflozin | Lexicon Pharmaceuticals | Hepatic Impairment, Healthy | 12/15 | | | |
NCT02940379: A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol |
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| Completed | 1 | 24 | US | sotagliflozin (SAR439954), midazolam, metoprolol | Sanofi | Type 2 Diabetes Mellitus | 12/16 | 12/16 | | |
NCT03070678: Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects |
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| Completed | 1 | 16 | Europe | Sotagliflozin (SAR439954), Mefenamic acid | Sanofi | Diabetes Mellitus | 04/17 | 04/17 | | |
NCT03063580: Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin |
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| Completed | 1 | 16 | Europe | Sotagliflozin (SAR439954), Rifampicin | Sanofi | Diabetes Mellitus | 05/17 | 05/17 | | |
| Completed | 1 | 76 | US | Sotagliflozin (SAR439954) | Sanofi | Type 2 Diabetes Mellitus | 08/17 | 08/17 | | |
NCT02647918: Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function |
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| Completed | 1 | 50 | US | Sotagliflozin | Lexicon Pharmaceuticals | Renal Impairment, Healthy | 09/17 | 09/17 | | |
NCT03174548: A Study to Evaluate the Effect of Food on the Pharmacokinetics of Sotagliflozin and to Explore the Relative Bioavailability in Healthy Subjects |
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| Completed | 1 | 14 | Europe | Sotagliflozin (SAR439954) | Sanofi | Diabetes Mellitus | 09/17 | 09/17 | | |
NCT03310944: Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects |
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| Completed | 1 | 12 | Europe | sotagliflozin (SAR439954) | Sanofi | Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus | 12/17 | 12/17 | | |
NCT03387657: A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide |
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| Completed | 1 | 16 | US | Sotagliflozin (SAR439954), Hydrochlorothiazide | Sanofi | Type 2 Diabetes Mellitus | 03/18 | 03/18 | | |
NCT03414723: A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril |
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| Completed | 1 | 16 | Europe | Sotagliflozin (SAR439954), Ramipril | Sanofi | Diabetes Mellitus, Healthy Subjects | 03/18 | 03/18 | | |
NCT03802487: Study To Determine Bioavailability of Sotagliflozin in Healthy Male and Female Subjects |
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| Completed | 1 | 6 | Europe | Sotagliflozin (SAR439954), 14C-microtracer, Charcoal | Sanofi | Type 2 Diabetes Mellitus, Healthy Subjects | 03/19 | 03/19 | | |
NCT03776227: A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions |
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| Completed | 1 | 66 | US | sotagliflozin (SAR439954) | Sanofi | Type 2 Diabetes Mellitus, Healthy Subjects | 04/19 | 04/19 | | |
NCT03909451: Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects |
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| Completed | 1 | 24 | RoW | Sotagliflozin (SAR439954), Placebo | Sanofi | Diabetes Mellitus | 08/19 | 08/19 | | |
| Not yet recruiting | 1 | 26 | NA | Sotagliflozin, Inpefa | University of Pennsylvania, National Heart, Lung, and Blood Institute (NHLBI) | Hypertrophic Cardiomyopathy Without Obstruction | 04/27 | 06/27 | | |
