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SGLT2 Inhibitor

Mizagliflozin for Post-Bariatric Hypoglycemia

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, 34 days

Awards & highlights

Study Summary

This trial will study the effects of a drug on blood sugar and insulin levels in people who have low blood sugar after weight-loss surgery.

Eligible Conditions

Post-Bariatric Hypoglycemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, 34 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, 34 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 34 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

Electrocardiograms

Glucose nadir after mizagliflozin dosing

+2 more

Secondary outcome measures

MMTT insulin concentration

MMTT plasma glucose concentration

MMTT time to peak insulin concentration after mizagliflozin dosing

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Arm BExperimental Treatment1 Intervention

Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2)

Group II: Treatment Arm AExperimental Treatment1 Intervention

Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mizagliflozin

2022

Completed Phase 2

~10

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Vogenx, Inc.Lead Sponsor

1 Previous Clinical Trials

15 Total Patients Enrolled

Frequently Asked Questions

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

Does Mizagliflozin have the green light from the FDA?

"Mizagliflozin's safety was given a score of 2 because, although there is some data supporting its safety, none of it suggests that the drug is effective."

Answered by AI

What are the goals that researchers hope to achieve with this clinical trial?

"The primary objective of the Vogenx clinical trial, which will be conducted over a 34-day period, is to evaluate laboratory tests. Additionally, the study will also assess secondary outcomes including time to peak insulin concentration after mizagliflozin dosing during MMTT, MMTT insulin concentrations area under the curve (AUC0-1, AUC0-2, AUC0-3, AUC0-4, and AUC0-6) after mizagliflozin dosing, and time to peak plasma glucose concentration after mizagliflozin dosing during M"

Answered by AI

Are participants still being accepted for this clinical trial?

"Yes, this study is still looking for patients to enroll. The trial was posted on September 13th, 2020 and updated October 11th, 2020 according to the clinicaltrials.gov website."

Answered by AI

What are the prerequisites for joining this clinical research project?

"The aim of this study is to enroll 9 individuals that suffer from hypoglycemia and meet the age criteria of being between 18-75 years old. There are additional requirements for participants which include: having had Roux-en-Y gastric bypass surgery over 6 months ago and a diagnosis of PBH."

Answered by AI

Do octogenarians fit the profile of patients this trial is designed to help?

"This study is open to individuals who are between the ages of 18 and 75."

Answered by AI

What is the projected sample size for this clinical trial?

"That is correct. Based on the information provided by clinicaltrials.gov, this study is looking for 9 individuals to fill 1 vacant position(s). The posting date was September 13th, 2022 with the most recent update being October 11th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05541939.