Overview
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-09-01
2023-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vogenx, Inc.
Criteria
Inclusion Criteria:- Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
- Diagnosis of PBH
Exclusion Criteria:
- History of current medical conditions (other than PBH) which may result in
hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune
hypoglycemia, congenital hyperinsulinemia.
- Current use of insulin or insulin secretagogues
- History of current fasting hypoglycemia
- Pregnancy and/or lactation: For women of childbearing potential: there is a
requirement for a negative urine pregnancy test and for agreement to use contraception
during the study and for at least 2 weeks after participating in the study