20 completed, 1 withdrawn. 10 Phase 1, 7 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 9, Withdrawn 1 |
| Phase 3 | 7 | Completed 7 |
| Phase 2 | 5 | Completed 5 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Absolute Bioavailability Study With Bexagliflozin Bexagliflozin - Type 2 Diabetes Mellitus | Phase 1 | Withdrawn | Theracos | 2018-08-01 | 2019-09-30 | |
| Safety and Efficacy of Bexagliflozin in Subjects With Moderate Hepatic Impairment Bexagliflozin - Type2 Diabetes Mellitus | Phase 1 | Completed | Theracos | 16 | 2018-07-26 | 2021-06-03 |
| Safety and Efficacy of Bexagliflozin Compared to Placebo as Add-on Therapy to Metformin in Type 2 Diabetes Subjects Bexagliflozin tablets, 20 mg, Bexagliflozin tablets, placebo - Type2 Diabetes Mellitus | Phase 3 | Completed | Theracos | 351 | 2017-11-28 | 2021-07-07 |
| An Integrated Assessment of the Safety and Effectiveness of Bexagliflozin for the Management of Essential Hypertension Bexagliflozin, Placebo - Essential Hypertension | Phase 2 / Phase 3 | Completed | Theracos | 673 | 2017-10-18 | 2021-09-21 |
| Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects Bexagliflozin, Sitagliptin, Placebo for sitagliptin - Type 2 Diabetes Mellitus | Phase 3 | Completed | Theracos | 386 | 2017-10-12 | 2021-06-22 |
| Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects Bexagliflozin, Probenecid, Rifampin - Type 2 Diabetes Mellitus | Phase 1 | Completed | Theracos | 48 | 2017-09-27 | 2021-07-01 |
| Bexagliflozin Drug/Drug Interaction Study With Digoxin Bexagliflozin, Digoxin - Type2 Diabetes Mellitus | Phase 1 | Completed | Theracos | 20 | 2017-07-24 | 2021-07-23 |
| Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection Bexagliflozin, Exenatide Injection - Type2 Diabetes Mellitus | Phase 1 | Completed | Theracos | 20 | 2017-05-24 | 2021-05-28 |
| Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin Bexagliflozin, Metformin, Glimepiride - Type2 Diabetes Mellitus | Phase 1 | Completed | Theracos | 54 | 2016-11-01 | 2021-07-22 |
| Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment Bexagliflozin, Placebo - Type 2 Diabetes Mellitus | Phase 3 | Completed | Theracos | 312 | 2016-09-23 | 2021-06-30 |
| Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects Bexagliflozin, Placebo for Bexagliflozin, Glimepiride - Type 2 Diabetes Mellitus | Phase 3 | Completed | Theracos | 426 | 2016-08-15 | 2021-05-27 |
| Study to Evaluate the Effects of a High-Fat Meal on Bexagliflozin in Healthy Subjects Bexagliflozin - Type 2 Diabetes Mellitus | Phase 1 | Completed | Theracos | 25 | 2016-06-20 | 2021-06-10 |
| Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes Bexagliflozin, Placebo - Type 2 Diabetes Mellitus | Phase 3 | Completed | Theracos | 210 | 2016-03-01 | 2021-06-28 |
| Bexagliflozin Efficacy and Safety Trial Bexagliflozin, Placebo - Type 2 Diabetes Mellitus | Phase 3 | Completed | Theracos | 1700 | 2015-10-01 | 2021-07-14 |
| A Dose Range Finding Study to Evaluate the Effect of Bexagliflozin Tablets in Subjects With Type 2 Diabetes Mellitus Bexagliflozin tablets, Bexagliflozin tablets, placebo - Diabetes Mellitus, Type 2 | Phase 2 | Completed | Theracos | 292 | 2015-05-12 | 2021-06-29 |
| Efficacy and Safety of EGT0001442 in Patients With Type 2 Diabetes Mellitus EGT0001442, Placebo - Diabetes Mellitus | Phase 2 | Completed | Theracos | 288 | 2011-12-01 | 2021-07-01 |
| Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects Sertraline plus Telenzepine - Obesity | Phase 1 | Completed | Theracos | 40 | 2010-05-01 | 2019-06-17 |
| Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus EGT0001442, Placebo capsules to match EGT0001442 - Diabetes Mellitus Type 2 | Phase 2 | Completed | Theracos | 151 | 2009-12-01 | 2021-06-16 |
| Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes EGT0001474, Placebo - Diabetes Mellitus Type 2 | Phase 1 | Completed | Theracos | 24 | 2009-06-01 | 2019-06-17 |
| Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers EGT0001474, Placebo - Safety and Tolerability of EGT0001474 in Healthy Volunteers | Phase 1 | Completed | Theracos | 78 | 2009-02-01 | 2019-06-06 |
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Diabetes Mellitus, Type 2 (12) · Obesity (2) · Weight Loss (2) · Anorexia (1) · Diabetes Mellitus (1) · Essential Hypertension (1) · Overweight (1)
bexagliflozin (16) · Sitagliptin Phosphate (2) · glimepiride (2) · Digoxin (1) · Exenatide (1) · Metformin (1) · Probenecid (1) · Rifampin (1) · Sertraline (1) · Verapamil (1) · telenzepine (1)
United States (19) · Japan (4) · Canada (3) · Poland (3) · Spain (3) · Czechia (2) · Russia (2) · Denmark (1) · France (1) · Germany (1) · Hungary (1) · Mexico (1) · Netherlands (1) · South Korea (1) · Sweden (1)
Mason Freeman, M.D. (5) · J. Paul Lock, MD (4) · Andrew Allegretti, M.D. (2) · Mason W Freeman, M.D. (2) · Mason W. Freeman, M.D. (2) · J Paul Lock, M.D. (1) · J. P. Lock, M.D. (1) · Jolene Berg, MD (1) · Natalie J Warner, MD (1) · Robert Williams, M.D. (1)