Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eiger BioPharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avexitide 45 mg twice daily then avexitide 90 mg once daily | Experimental | 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 |
|
| Avexitide 45 mg once daily then avexitide 90 mg twice daily | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avexitide | Drug | Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marilyn Tan, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Research Unit | Palo Alto | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
25 participants entered a 14-day run-in (screening) period during which they wore the continuous glucose monitor (CGM). 17 participants who had at least 2 hypoglycemic events were randomized to a study arm.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Run-in (All Participants) | 14-day run-in period during which hypoglycemic events were recorded by CGM. |
| FG001 | Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once Daily | Patients receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days |
| FG002 | Avexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily | Patients receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in Period (14 Days) |
| |||||||||||||
| Treatment Period 1 (14 Days) |
| |||||||||||||
| Washout Period (2 Days) |
| |||||||||||||
| Treatment Period 2 (14 Days |
|
Participants with no major protocol deviations who were allocated to treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once Daily | Patients receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days |
| BG001 | Avexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with no major protocol deviations who were allocated to treatment. | Posted | Mean | Standard Deviation | events per 14 days | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) |
|
44 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Period | Adverse events collected during the run-in period | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marilyn Tan, MD, FACE | Stanford University | (650) 721-1300 | mjtan@stanford.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2021 | Mar 23, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C083773 | exendin (9-39) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| 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) |
| 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) |
| Postprandial Glycemia During Standardized Mixed Meal Consumption | Change from Baseline in glycemia During Standardized Mixed Meal Consumption | 3 Hours Following Standardized Liquid Meal |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Patients receive one of the two dosing regimens of avexitide for 14 days followed by the other dosing regimen of avextide for 14 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Avexitide 90 mg Once Daily |
Patients receive avexitide 90 mg once daily for 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. | Participants with no major protocol deviations who were allocated to treatment. | Posted | Mean | Standard Deviation | episodes per 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. | Participants with no major protocol deviations who were allocated to treatment. | Posted | Mean | Standard Deviation | events per 14 days | 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. | Participants with no major protocol deviations who were allocated to treatment. | Posted | Mean | Standard Deviation | percentage of time per 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. | Participants with no major protocol deviations who were allocated to treatment. | Posted | Mean | Standard Deviation | percentage of time per 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 | Data were not collected for this outcome | Posted | 3 Hours Following Standardized Liquid Meal |
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Avexitide 45 mg Twice Daily | Adverse events collected during the avexitide 45 mg twice daily treatment period | 0 | 17 | 0 | 17 | 7 | 17 |
| EG002 | Avexitide 90 mg Once Daily | Adverse events collected during the avexitide 90 mg once daily treatment period | 0 | 17 | 0 | 17 | 8 | 17 |
| loose stools | Gastrointestinal disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 0.0043 |
A p-value of <0.05 would be considered statistically significant |
| Other |
| 0.0003 |
A p-value of <0.05 would be considered statistically significant |
| Other |
| t-test, 2 sided |
| 0.201 |
A p-value of <0.05 would be considered statistically significant |
| Mean Difference (Net) |
| -35.66 |
| 2-Sided |
| Other |
| Within-group analysis of change from baseline | t-test, 2 sided | 0.001 | A p-value of <0.05 would be considered statistically significant | Mean Difference (Net) | -67.65 | 2-Sided | Other |
| t-test, 2 sided |
| 0.111 |
A p-value of <0.05 would be considered statistically significant |
| Mean Difference (Net) |
| -31.88 |
| 2-Sided |
Change in percentage |
| Other |
| Within-group analysis of change from baseline | t-test, 2 sided | 0.001 | A p-value of <0.05 would be considered statistically significant | Mean Difference (Net) | -53.37 | 2-Sided | Change in percentage | Other |