What side effects are associated with this type of intervention?

Common treatments for Post-Bariatric Hypoglycemia, such as SGLT2 inhibitors like Mizagliflozin, can have side effects including urinary tract infections, genital infections, and dehydration due to increased glucose excretion. Other potential side effects may include dizziness, hypotension, and an increased risk of ketoacidosis. It is important for patients to discuss these risks with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

There are no specific FDA approvals for the treatment of Post-Bariatric Hypoglycemia (PBH) using SGLT2 inhibitors. However, SGLT2 inhibitors such as canagliflozin, dapagliflozin, and empagliflozin have been approved for the treatment of type 2 diabetes mellitus. These drugs reduce glucose reabsorption in the kidneys, leading to increased glucose excretion and lower blood glucose levels, which is similar to the mechanism being studied for Mizagliflozin in PBH.

What other types of research exist?

Promising novel alternatives to Mizagliflozin for Post-Bariatric Hypoglycemia patients include Tirzepatide (a dual GIP and GLP-1 receptor agonist) and Semaglutide (a GLP-1 receptor agonist). These medications have shown efficacy in managing blood glucose levels and may offer effective treatment options for PBH patients.

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SGLT2 Inhibitor

Mizagliflozin for Low Blood Sugar

Phase 2

Waitlist Available

Research Sponsored by Vogenx, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, 43 days

Summary

This trial is testing mizagliflozin, a medication that helps manage blood sugar levels after eating. It targets people who have low blood sugar after bariatric surgery. The study will see if mizagliflozin reduces negative effects and stabilizes blood sugar.

Who is the study for?

This trial is for individuals who have had Roux-en-Y gastric bypass surgery over 6 months ago and are diagnosed with post-bariatric hypoglycemia (PBH). Participants must not be pregnant, using insulin or drugs that increase insulin release, and should not have other conditions causing low blood sugar.

What is being tested?

The study tests the effects of Mizagliflozin—a drug—on adverse events and how it affects blood sugar levels after eating in people with PBH. It's a phase 2 trial where participants will receive either Mizagliflozin or a placebo without knowing which one they're getting.

What are the potential side effects?

Possible side effects of Mizagliflozin may include digestive issues, dehydration due to increased urination, dizziness or lightheadedness especially when standing up, kidney problems, and genital yeast infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 43 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 43 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 43 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Glucose nadir after dosing

Laboratory Tests

+1 more

Secondary study objectives

MMTT glucose concentration

MMTT insulin concentration

MMTT peak glucose concentration after dosing

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment2 Interventions

Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.

Group II: Cohort 1Experimental Treatment2 Interventions

Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mizagliflozin

2022

Completed Phase 2

~10

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

SGLT2 inhibitors, such as Mizagliflozin, work by reducing glucose reabsorption in the kidneys, which leads to increased glucose excretion and lower blood glucose levels. This mechanism is crucial for Post-Bariatric Hypoglycemia (PBH) patients as it helps manage the frequent and severe drops in blood glucose levels that can occur after bariatric surgery. By stabilizing blood sugar levels, SGLT2 inhibitors reduce the risk of hypoglycemic episodes, thereby improving the quality of life for these patients.

Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus.