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

Primary Purpose

Postbariatric Hypoglycemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mizagliflozin
Sponsored by
Vogenx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postbariatric Hypoglycemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Stanford
  • University of Colorado / Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm A

Treatment Arm B

Arm Description

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

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

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
Electrocardiograms
Number of participants with abnormal electrocardiograms
Glucose nadir after mizagliflozin dosing
Time course of glucose concentrations during MMTT

Secondary Outcome Measures

MMTT time to peak plasma glucose concentration after mizagliflozin dosing
Time course of glucose concentrations during MMTT
MMTT plasma glucose concentration
MMTT plasma glucose area under the curve (AUC0-1, AUC0-2, AUC0-3) after mizagliflozin dosing
MMTT time to peak insulin concentration after mizagliflozin dosing
Time course of insulin concentrations during MMTT
MMTT insulin concentration
MMTT insulin concentrations area under the curve (AUC0-1, AUC0-2, AUC0-3, AUC0-4, and AUC0-6) after mizagliflozin dosing
Peak plasma glucose concentration after mizagliflozin dosing.
Time course of glucose concentrations during MMTT
Peak insulin concentration after mizagliflozin dosing
Time course of insulin concentrations during MMTT

Full Information

First Posted
September 8, 2022
Last Updated
May 10, 2023
Sponsor
Vogenx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05541939
Brief Title
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)

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 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).
Detailed Description
This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).

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
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A
Arm Type
Experimental
Arm Description
Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin
Arm Title
Treatment Arm B
Arm Type
Experimental
Arm Description
Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2)
Intervention Type
Drug
Intervention Name(s)
Mizagliflozin
Intervention Description
Encapsulated or Liquid Formulation
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants with Adverse events
Time Frame
Through study completion, 34 days
Title
Vital Signs
Description
Number of participants with abnormal vital signs
Time Frame
Through study completion, 34 days
Title
Laboratory Tests
Description
Number of participants with abnormal laboratory tests
Time Frame
Through study completion, 34 days
Title
Electrocardiograms
Description
Number of participants with abnormal electrocardiograms
Time Frame
Through study completion, 34 days
Title
Glucose nadir after mizagliflozin dosing
Description
Time course of glucose concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Secondary Outcome Measure Information:
Title
MMTT time to peak plasma glucose concentration after mizagliflozin dosing
Description
Time course of glucose concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Title
MMTT plasma glucose concentration
Description
MMTT plasma glucose area under the curve (AUC0-1, AUC0-2, AUC0-3) after mizagliflozin dosing
Time Frame
0-3 hours following liquid meal
Title
MMTT time to peak insulin concentration after mizagliflozin dosing
Description
Time course of insulin concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Title
MMTT insulin concentration
Description
MMTT insulin concentrations area under the curve (AUC0-1, AUC0-2, AUC0-3, AUC0-4, and AUC0-6) after mizagliflozin dosing
Time Frame
0-6 hours following liquid meal
Title
Peak plasma glucose concentration after mizagliflozin dosing.
Description
Time course of glucose concentrations during MMTT
Time Frame
0-3 hours following liquid meal
Title
Peak insulin concentration after mizagliflozin dosing
Description
Time course of insulin concentrations during MMTT
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 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.
Facility Information:
Facility Name
Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado / Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

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

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