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

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

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).

Study Overview

• Status: Completed
• Conditions: Postbariatric Hypoglycemia
• Intervention / Treatment: Drug: Mizagliflozin

Detailed 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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado / Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm A; Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin	Drug: Mizagliflozin; Encapsulated or Liquid Formulation
Experimental: Treatment Arm B; Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2)	Drug: Mizagliflozin; Encapsulated or Liquid Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Nadir After Mizagliflozin Dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
MMTT time to peak plasma glucose concentration after mizagliflozin dosing	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
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
MMTT time to peak insulin concentration after mizagliflozin dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal
Peak plasma glucose concentration after mizagliflozin dosing.	Time course of glucose concentrations during MMTT	0-3 hours following liquid meal
Peak insulin concentration after mizagliflozin dosing	Time course of insulin concentrations during MMTT	0-3 hours following liquid meal

Collaborators and Investigators

• Sponsor: Vogenx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: VGX-001-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No