Phase 2
N=9
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Postbariatric Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT05541939 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Glucose Nadir After Mizagliflozin Dosing — 6.2; 4.0; 17.5; 31.5 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mizagliflozin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vogenx, Inc.
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Nadir After Mizagliflozin Dosing |
6.2; 4.0; 17.5; 31.5 | — |
Summary
This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).
Eligibility 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 dumping syndrome.
- 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.
Data sourced from ClinicalTrials.gov (NCT05541939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.