Back to resultsAvexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Primary Purpose
Acquired Hyperinsulinemic Hypoglycemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Avexitide
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Hyperinsulinemic Hypoglycemia focused on measuring Post Bariatric Hypoglycemia, avexitide, Post-Bariatric Hypoglycemia, Post-gastrectomy hypoglycemia, Post gastrectomy hypoglycemia, Post-esophagectomy hypoglycemia, Post esophagectomy hypoglycemia, Post-Nissen Fundoplication hypoglycemia, Post Nissen Fundoplication hypoglycemia, Exendin (9-39), Exendin 9-39
Eligibility Criteria
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
Sites / Locations
- Clinical and Translational Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Avexitide 45 mg twice daily then avexitide 90 mg once daily
Avexitide 45 mg once daily then avexitide 90 mg twice daily
Arm Description
Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days
Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)
Percentage of time in level 1 hypoglycemia (<70mg/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.
Postprandial Glycemia During Standardized Mixed Meal Consumption
Change from Baseline in glycemia During Standardized Mixed Meal Consumption
Full Information
NCT ID
NCT04652479
First Posted
October 27, 2020
Last Updated
May 12, 2023
Sponsor
Dr. Tracey McLaughlin, MD
Collaborators
Eiger BioPharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04652479
Brief Title
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Official Title
A Phase 2, Open-Label, Cross-over Study to Assess the Safety and Efficacy of Avexitide in Acquired Hyperinsulinemic Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Tracey McLaughlin, MD
Collaborators
Eiger BioPharmaceuticals
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Hyperinsulinemic Hypoglycemia
Keywords
Post Bariatric Hypoglycemia, avexitide, Post-Bariatric Hypoglycemia, Post-gastrectomy hypoglycemia, Post gastrectomy hypoglycemia, Post-esophagectomy hypoglycemia, Post esophagectomy hypoglycemia, Post-Nissen Fundoplication hypoglycemia, Post Nissen Fundoplication hypoglycemia, Exendin (9-39), Exendin 9-39
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avexitide 45 mg twice daily then avexitide 90 mg once daily
Arm Type
Experimental
Arm Description
Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days
Arm Title
Avexitide 45 mg once daily then avexitide 90 mg twice daily
Arm Type
Experimental
Arm Description
Patients will receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days
Intervention Type
Drug
Intervention Name(s)
Avexitide
Intervention Description
Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
Primary Outcome Measure Information:
Title
Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH)
Description
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 Outcome Measure Information:
Title
Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG
Description
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)
Title
Rate of Level 3 Hypoglycemia
Description
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)
Title
Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time)
Description
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)
Title
Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time)
Description
Percentage of time in level 1 hypoglycemia (<70mg/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)
Title
Postprandial Glycemia During Standardized Mixed Meal Consumption
Description
Change from Baseline in glycemia During Standardized Mixed Meal Consumption
Time Frame
3 Hours Following Standardized Liquid Meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn Tan, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Clinical and Translational Research Unit
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
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