The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    vogenx
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05541939
Recruitment Status : Completed
First Posted : September 15, 2022
Last Update Posted : May 12, 2023
Sponsor:
Information provided by (Responsible Party):
Vogenx, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Postbariatric Hypoglycemia Drug: Mizagliflozin Phase 2

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).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 13, 2022
Actual Primary Completion Date : February 17, 2023
Actual Study Completion Date : February 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment Arm A
Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin
 Drug: Mizagliflozin
Encapsulated or Liquid Formulation
Experimental: Treatment Arm B
Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2)
 Drug: Mizagliflozin
Encapsulated or Liquid Formulation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Through study completion, 34 days ]
    Number of participants with Adverse events

  2. Vital Signs [ Time Frame: Through study completion, 34 days ]
    Number of participants with abnormal vital signs

  3. Laboratory Tests [ Time Frame: Through study completion, 34 days ]
    Number of participants with abnormal laboratory tests

  4. Electrocardiograms [ Time Frame: Through study completion, 34 days ]
    Number of participants with abnormal electrocardiograms

  5. Glucose nadir after mizagliflozin dosing [ Time Frame: 0-3 hours following liquid meal ]
    Time course of glucose concentrations during MMTT


Secondary Outcome Measures :
  1. MMTT time to peak plasma glucose concentration after mizagliflozin dosing [ Time Frame: 0-3 hours following liquid meal ]
    Time course of glucose concentrations during MMTT

  2. MMTT plasma glucose concentration [ Time Frame: 0-3 hours following liquid meal ]
    MMTT plasma glucose area under the curve (AUC0-1, AUC0-2, AUC0-3) after mizagliflozin dosing

  3. MMTT time to peak insulin concentration after mizagliflozin dosing [ Time Frame: 0-3 hours following liquid meal ]
    Time course of insulin concentrations during MMTT

  4. MMTT insulin concentration [ Time Frame: 0-6 hours following liquid meal ]
    MMTT insulin concentrations area under the curve (AUC0-1, AUC0-2, AUC0-3, AUC0-4, and AUC0-6) after mizagliflozin dosing

  5. Peak plasma glucose concentration after mizagliflozin dosing. [ Time Frame: 0-3 hours following liquid meal ]
    Time course of glucose concentrations during MMTT

  6. Peak insulin concentration after mizagliflozin dosing [ Time Frame: 0-3 hours following liquid meal ]
    Time course of insulin concentrations during MMTT


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05541939


Locations
Layout table for location information
United States, California
Stanford
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado / Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Vogenx, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Vogenx, Inc.
ClinicalTrials.gov Identifier: NCT05541939    
Other Study ID Numbers: VGX-001-011
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases