Mizagliflozin for Post-Bariatric Hypoglycemia

Stanford, Palo Alto, CA
Post-Bariatric HypoglycemiaMizagliflozin - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: Through study completion, 34 days

Hour 3
Glucose nadir after mizagliflozin dosing
MMTT plasma glucose concentration
MMTT time to peak insulin concentration after mizagliflozin dosing
MMTT time to peak plasma glucose concentration after mizagliflozin dosing
Peak insulin concentration after mizagliflozin dosing
Peak plasma glucose concentration after mizagliflozin dosing.
Hour 6
MMTT insulin concentration
Day 34
Adverse Events
Electrocardiograms
Laboratory Tests
Vital Signs

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Treatment Arm A
1 of 2
Treatment Arm B
1 of 2

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Mizagliflozin · No Placebo Group · Phase 2

Treatment Arm A
Drug
Experimental Group · 1 Intervention: Mizagliflozin · Intervention Types: Drug
Treatment Arm B
Drug
Experimental Group · 1 Intervention: Mizagliflozin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mizagliflozin
2022
Completed Phase 2
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, 34 days

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 75 · All Participants · 2 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.