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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
Awards & highlights

Study Summary

This trial tests a drug to see if it can reduce side effects and lower blood sugar levels after eating.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Glucose nadir after dosing
Laboratory Tests
+1 more
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Vogenx, Inc.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Mizagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05721729 — Phase 2
Post-Bariatric Hypoglycemia Research Study Groups: Cohort 1, Cohort 2
Post-Bariatric Hypoglycemia Clinical Trial 2023: Mizagliflozin Highlights & Side Effects. Trial Name: NCT05721729 — Phase 2
Mizagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721729 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people aged 65 and over participate in this research?

"To be considered for this research program, individuals must fall between the ages 18 to 75. Other trials are available that accept minors and seniors aged 65 and over; 10 studies cater to children while 59 focus on elderly patients."

Answered by AI

Are there any vacancies remaining in the trial for participants?

"On clinicaltrials.gov, this study is currently recruiting potential patients. The listing was first published on June 23rd, 2023 and the details were recently updated on June 28th of the same year."

Answered by AI

Has the regulatory body green-lighted Cohort 1 for commercialization?

"Cohort 1 has been deemed relatively safe, garnering a score of 2 according to the Power team. This is because there are some indications that it can be tolerated by patients and no data suggesting efficacy in Phase 2 trials."

Answered by AI

How many participants is the research project accommodating?

"Affirmative. As indicated on clinicaltrials.gov, this health study is still recruiting patients to participate in the trial that commenced on June 23rd 2023 and was recently updated on June 28th 2023. The investigators of this research are seeking 15 test subjects at a single site."

Answered by AI

Is there any opportunity to participate in this medical research?

"Aspiring enrollees for this trial must suffer from post-bariatric hypoglycemia and be between the ages of 18 to 75. In total, 15 individuals will ultimately take part in the study."

Answered by AI

What are the intended outcomes of this clinical investigation?

"This 43-day trial seeks to observe the impact of an intervention on Vital Signs. Secondary objectives include measuring MMTT glucose area under curve (AUC0-1, AUC0-2, and AUC0-3) after dosing, peak insulin concentration during MMTT, and time lapse until reaching this peak insulin concentration after administering a dose."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
2023. "Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721729.
All > Hypoglycemia
~0 spots leftby May 2024
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