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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05541939
• Other study ID #: VGX-001-011
• Status: Completed
• Phase: Phase 2
• Start date: September 13, 2022
• Est. completion date: February 17, 2023

Study information

• Verified date: May 2023
• Source: Vogenx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• 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 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.

Related Conditions & MeSH terms

• Hypoglycemia
• Postbariatric Hypoglycemia

Intervention

Drug:
• Mizagliflozin
Encapsulated or Liquid Formulation

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, 34 days
Primary	Vital Signs	Number of participants with abnormal vital signs	Through study completion, 34 days
Primary	Laboratory Tests	Number of participants with abnormal laboratory tests	Through study completion, 34 days
Primary	Electrocardiograms	Number of participants with abnormal electrocardiograms	Through study completion, 34 days
Primary	Glucose nadir after mizagliflozin dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT time to peak plasma glucose concentration after mizagliflozin dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT plasma glucose concentration	MMTT plasma glucose area under the curve (AUC0-1, AUC0-2, AUC0-3) after mizagliflozin dosing	0-3 hours following liquid meal
Secondary	MMTT time to peak insulin concentration after mizagliflozin dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal
Secondary	MMTT insulin concentration	MMTT insulin concentrations area under the curve (AUC0-1, AUC0-2, AUC0-3, AUC0-4, and AUC0-6) after mizagliflozin dosing	0-6 hours following liquid meal
Secondary	Peak plasma glucose concentration after mizagliflozin dosing.	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
Secondary	Peak insulin concentration after mizagliflozin dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal