Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions

Postbariatric Hypoglycemia Clinical Trial

Official title:

Phase 2 Crossover, Randomized, Placebo-Controlled, Single-Blind, Repeat Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin on Adverse Events and Postprandial Glucose Excursions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05721729
• Other study ID #: VGX-001-012
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 23, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Vogenx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to complete the study. Subjects will be randomly assigned to a treatment arm within a cohort. Each subject should receive placebo and 2 active dose regimens in a crossover fashion.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Postbariatric Hypoglycemia

Intervention

Drug:
• Mizagliflozin
Encapsulated
• Placebo
Encapsulated

Locations

Country	Name	City	State
United States	University of Colorado / Anschutz Medical Campus	Aurora	Colorado
United States	Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Vogenx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants with adverse events	Through study completion, 43 days
Primary	Vital Signs	Number of participants with abnormal vital signs	Through study completion, 43 days
Primary	Laboratory Tests	Number of participants with abnormal laboratory tests	Through study completion, 43 days
Primary	Glucose nadir after dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT peak glucose concentration after dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT peak insulin concentration after dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT time to peak glucose concentration after dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT time to peak insulin concentration after dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT glucose concentration	MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing	0-3 hours following liquid meal
Secondary	MMTT insulin concentration	MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing	0-3 hours following liquid meal