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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
5mg mizagliflozin capsules orally administered TID for 28 days
10mg mizagliflozin capsules orally administered TID for 28 days
Placebo capsules orally administered TID for 28 days
Number of combined Level 2 (as measured by self-monitored blood glucose) and Level 3 hypoglycemic events (as measured by diary entry and adjudicated)
Time frame: During the double-blind treatment period (approximately 28 days)
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