Postbariatric Hypoglycemia
Conditions
Brief summary
VGX-001-013 (EMERGE) is a Phase 2b study to evaluate an investigational new drug, mizagliflozin, for safety, tolerability and its ability to prevent low blood sugar in patients with post-bariatric hypoglycemia.
Detailed description
This is a phase 2b randomized, placebo-controlled, double-blind, repeat dose parallel group study in patients with post-bariatric hypoglycemia (PBH) to determine the effect of mizagliflozin on safety, postprandial glucose excursions and reduction in hypoglycemic events.
Interventions
DRUGMizagliflozin 5 mg
5mg mizagliflozin capsules orally administered TID for 28 days
DRUGMizagliflozin 10 mg
10mg mizagliflozin capsules orally administered TID for 28 days
DRUGPlacebo
Placebo capsules orally administered TID for 28 days
Sponsors
Vogenx, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and nonpregnant females, ages ≥18 years old, having had Roux-en-Y bariatric surgery more than 12 months prior to signing the ICF. * History of reactive hypoglycemia with Whipple's triad: the occurrence of hypoglycemic symptoms associated with blood glucose of \<54 mg/dL, and resolution with glucose or carbohydrate administration. Symptoms associated with reactive hypoglycemia include neuroglycopenic symptoms (e.g., behavioral changes, confusion or impaired cognitive function, seizure, loss of consciousness). * Willing and able to give informed consent and follow all study procedures and requirements. * Participants (male and female) must agree to use an adequate method of contraception * Has recurrent hypoglycemia of at least 4 episodes during a 3-week Run-In period.
Exclusion criteria
* History of current medical conditions excluding PBH which may result in hypoglycemia). * Current use of insulin or insulin secretagogues. * Current use of GLP-1 agonists, GLP-1/GIP dual agonists, or GLP-1 antagonists. Unless participants have been through a 'wash-out' period * Current use of drugs that may affect CGM function (e.g., acetaminophen/paracetamol). * History of recent fasting hypoglycemia. * Participants with rectal prolapse or pelvic floor dysfunction within 6 months of Screening. * Congestive heart failure, New York Heart Association class II, III or IV within 6 months of Screening. * History of myocardial infarction, unstable angina, or revascularization within 6 months of Screening. * History of a cerebrovascular accident within 6 months of Screening. * Active malignancy, except basal cell or squamous cell skin cancers. * Major surgical operation within 30 days of Screening. * Active alcohol abuse or substance abuse. * 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. * Other participants considered by the investigator to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated) | During the double-blind treatment period (approximately 28 days) |
Outcome results
None listed