The study of effect of Mizagliflozin on postprandial glucose and insulin in post-bariatric hypoglycemia subjects

The research company Vogenx, Inc is conducting the clinical trial Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects.

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).

It is planned to include 9 participants. Actual study start date is September 2022. The researchers expect to complete the study by February 2023. The study is conducted at the University of Colorado / Anschutz Medical Campus, Aurora, Colorado, United States.

One primary outcome measure is number of participants with abnormal electrocardiograms. The inclusion criteria are Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment and diagnosis of PBH. 

Among the exclusion criteria are 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.

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05541939.