Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mizagliflozin · 3 trials · 1 indication
Number of participants with adverse events
Number of participants with abnormal vital signs
Number of participants with abnormal laboratory tests
Time course of glucose concentrations during MMTT
Time course of glucose concentrations during MMTT
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Mizagliflozin 5mg | EXPERIMENTAL | - |
| Mizagliflozin 10mg | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined. |
| Cohort 2 | EXPERIMENTAL | Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined. |
| Treatment Arm A | EXPERIMENTAL | Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin |
| Treatment Arm B | EXPERIMENTAL | Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2) |
| Name | Type | Description |
|---|---|---|
| Mizagliflozin 5 mg | DRUG | 5mg mizagliflozin capsules orally administered TID for 28 days |
| Mizagliflozin 10 mg | DRUG | 10mg mizagliflozin capsules orally administered TID for 28 days |
| Placebo | DRUG | Placebo capsules orally administered TID for 28 days |
| Mizagliflozin | DRUG | Encapsulated |
Inclusion Criteria: * Males and nonpregnant females, ages ≥18 years old, having had Roux-en-Y bariatric surgery more than 12 months prior to signing the ICF. * History of reactive hypoglycemia with Whipple's triad: the occurrence of hypoglycemic symptoms associated with blood glucose of \<54 mg/dL,...