Back to resultsEffect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
Primary Purpose
Postbariatric Hypoglycemia
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mizagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postbariatric Hypoglycemia
Eligibility Criteria
Inclusion Criteria: Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment Diagnosis of PBH Exclusion Criteria: 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 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
Sites / Locations
- StanfordRecruiting
- University of Colorado / Anschutz Medical CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.
Outcomes
Primary Outcome Measures
Adverse Events
Number of participants with adverse events
Vital Signs
Number of participants with abnormal vital signs
Laboratory Tests
Number of participants with abnormal laboratory tests
Glucose nadir after dosing
Time course of glucose concentrations during MMTT
Secondary Outcome Measures
MMTT peak glucose concentration after dosing
Time course of glucose concentrations during MMTT
MMTT peak insulin concentration after dosing
Time course of insulin concentrations during MMTT
MMTT time to peak glucose concentration after dosing
Time course of glucose concentrations during MMTT
MMTT time to peak insulin concentration after dosing
Time course of insulin concentrations during MMTT
MMTT glucose concentration
MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
MMTT insulin concentration
MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05721729
Brief Title
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
Official Title
Phase 2 Crossover, Randomized, Placebo-Controlled, Single-Blind, Repeat Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin on Adverse Events and Postprandial Glucose Excursions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vogenx, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.
Detailed Description
This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions. This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to complete the study. Subjects will be randomly assigned to a treatment arm within a cohort. Each subject should receive placebo and 2 active dose regimens in a crossover fashion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postbariatric Hypoglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.
Intervention Type
Drug
Intervention Name(s)
Mizagliflozin
Intervention Description
Encapsulated
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Encapsulated
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants with adverse events
Time Frame
Through study completion, 43 days
Title
Vital Signs
Description
Number of participants with abnormal vital signs
Time Frame
Through study completion, 43 days
Title
Laboratory Tests
Description
Number of participants with abnormal laboratory tests
Time Frame
Through study completion, 43 days
Title
Glucose nadir after dosing
Description
Time course of glucose concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Secondary Outcome Measure Information:
Title
MMTT peak glucose concentration after dosing
Description
Time course of glucose concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Title
MMTT peak insulin concentration after dosing
Description
Time course of insulin concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Title
MMTT time to peak glucose concentration after dosing
Description
Time course of glucose concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Title
MMTT time to peak insulin concentration after dosing
Description
Time course of insulin concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Title
MMTT glucose concentration
Description
MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
Time Frame
0-3 hours following liquid meal
Title
MMTT insulin concentration
Description
MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
Time Frame
0-3 hours following liquid meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
Diagnosis of PBH
Exclusion Criteria:
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 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
Facility Information:
Facility Name
Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Turk
Phone
650-888-0144
Email
nturk@stanford.edu
Facility Name
University of Colorado / Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anagha Champakanath
Phone
303-724-1290
Email
ANAGHA.CHAMPAKANATH@CUANSCHUTZ.EDU
12. IPD Sharing Statement
Learn more about this trial
Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
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