Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Phase 2 Randomized Single Ascending Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin Formulations on Postprandial Glucose and Insulin Levels
1 other identifier
interventional
9
1 country
2
Brief Summary
This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2022
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2023
CompletedResults Posted
Study results publicly available
June 25, 2024
CompletedJune 25, 2024
May 1, 2024
5 months
September 8, 2022
May 2, 2024
June 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose Nadir After Mizagliflozin Dosing
Time course of glucose concentrations during MMTT
0-3 hours following liquid meal
Study Arms (2)
Treatment Arm A
EXPERIMENTALSubjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin
Treatment Arm B
EXPERIMENTALSubjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2)
Interventions
Eligibility Criteria
You may qualify if:
- Roux-en-Y gastric bypass surgery performed \> 6 months prior to enrollment
- Diagnosis of PBH
You may not qualify if:
- History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
- Current use of insulin or insulin secretagogues.
- History of current dumping syndrome.
- History of current fasting hypoglycemia.
- Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vogenx, Inc.lead
Study Sites (2)
Stanford
Palo Alto, California, 94304, United States
University of Colorado / Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- Vogenx
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2022
First Posted
September 15, 2022
Study Start
September 13, 2022
Primary Completion
February 17, 2023
Study Completion
February 17, 2023
Last Updated
June 25, 2024
Results First Posted
June 25, 2024
Record last verified: 2024-05