Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia

Dr. Tracey McLaughlin, MD25 enrolled

Overview

The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic Hypoglycemia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acquired Hyperinsulinemic Hypoglycemia

Interventions

AvexitideDRUG

Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of bariatric or upper-gastrointestinal surgery (RYGB, VSG, gastrectomy, esophagectomy, or Nissen fundoplication) at least 12 months prior to the start of Screening * History of recurrent hypoglycemia occurring after bariatric or upper-GI surgery, as documented in the medical record. * Body mass index (BMI) of up to 40 kg/m2 * If female, must not be breastfeeding and must have a negative urine pregnancy test result Exclusion Criteria: * Major surgery within 6 months before randomization. * History of or current hyperinsulinism other than Acquired Hyperinsulinism (e.g., insulin autoimmune hypoglycemia). * Use of agents that may interfere with glucose metabolism

Locations (1)

Clinical and Translational Research Unit

Palo Alto, California, United States

Outcomes

Primary Outcomes

Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)

Level 2 hypoglycemia events (ADA, \<54 mg/dL) as measured by CGM and defined as the number of events captured by CGM with glucose measures \<54 mg/dL during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.

Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

Secondary Outcomes

Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG

Distinct episodes of Level 2 hypoglycemia (SMBG glucose \<54 mg/dL), divided by number of days for run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.

Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

Rate of Level 3 Hypoglycemia

Severe events during each treatment period characterized by altered mental and/or physical functioning that requires assistance from another person for recovery; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. This would apply regardless of whether a patient actually received external assistance.

Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)

Percentage of time in level 2 hypoglycemia (\<54mg/dL by CGM) during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days.

Time frame: Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)

Data from ClinicalTrials.gov

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