Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects

Postbariatric Hypoglycemia Clinical Trial

Official title:
Phase 2 Randomized Single Ascending Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin Formulations on Postprandial Glucose and Insulin Levels

Status Completed

Clinical Trial 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).

Clinical Trial Description

This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05541939
Study type	Interventional
Source	Vogenx, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	September 13, 2022
Completion date	February 17, 2023

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See also
Status	Clinical Trial	Phase
Recruiting	`NCT06036784` - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects	Phase 1
Completed	`NCT03373435` - Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia	Phase 2
Active, not recruiting	`NCT05721729` - Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions	Phase 2