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SGLT2 Inhibitor

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

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 0-6 hours following liquid meal
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and effects of mizagliflozin, a medication taken by mouth, on blood sugar levels in patients who have low blood sugar after bariatric surgery. Mizagliflozin has shown potential in improving chronic constipation.

Eligible Conditions
  • Post-Bariatric Hypoglycemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6 hours following liquid meal
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6 hours following liquid meal for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glucose Nadir After Mizagliflozin Dosing
Secondary study objectives
MMTT insulin concentration
MMTT plasma glucose concentration
MMTT time to peak insulin concentration after mizagliflozin dosing
+3 more

Side effects data

From 2023 Phase 2 trial • 9 Patients • NCT05541939
25%
Abdominal distension
25%
Diarrhoea
25%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Arm B Period 2 (10.0 mg Capsule)
Treatment Arm A Period 2 (5.0 mg Capsule)
Treatment Arm B Period 1 (2.5 mg Liquid Formulation)
Treatment Arm A Period 1 (2.5 mg Capsule)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Vogenx, Inc.Lead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
~3 spots leftby Dec 2025
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