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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04652479
Other study ID # 52880
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 21, 2021
Est. completion date June 30, 2022

Study information

Verified date May 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Clinical and Translational Research Unit Palo Alto California

Sponsors (2)

Lead Sponsor Collaborator
Dr. Tracey McLaughlin, MD Eiger BioPharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary 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. Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary 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. Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary 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. Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary 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. Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days)
Secondary Postprandial Glycemia During Standardized Mixed Meal Consumption Change from Baseline in glycemia During Standardized Mixed Meal Consumption 3 Hours Following Standardized Liquid Meal