Trial · NCT04652479
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
NCT04652479, Phase 2, Completed, Dr. Tracey McLaughlin, MD; results first posted 2023-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia. Trials, record NCT04652479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04652479
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
- NCT number
- NCT04652479
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Dr. Tracey McLaughlin, MD
- Conditions
- Acquired Hyperinsulinemic Hypoglycemia
- Interventions
- Avexitide
- First posted
- 2020-12-03
- Last updated
- 2023-06-09
- Results first posted
- 2023-06-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | 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 | Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | 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. |
| Secondary | Rate of Level 3 Hypoglycemia | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | 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. |
| Secondary | Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time) | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | 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. |
| Secondary | Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time) | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | 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. |
| Secondary | Postprandial Glycemia During Standardized Mixed Meal Consumption | 3 Hours Following Standardized Liquid Meal | Change from Baseline in glycemia During Standardized Mixed Meal Consumption |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | Participants with no major protocol deviations who were allocated to treatment. | events per 14 days | MEAN |
| SECONDARY | Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | Participants with no major protocol deviations who were allocated to treatment. | episodes per 14 days | MEAN |
| SECONDARY | Rate of Level 3 Hypoglycemia | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | Participants with no major protocol deviations who were allocated to treatment. | events per 14 days | MEAN |
| SECONDARY | Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time) | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | Participants with no major protocol deviations who were allocated to treatment. | percentage of time per 14 days | MEAN |
| SECONDARY | Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time) | Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) | Participants with no major protocol deviations who were allocated to treatment. | percentage of time per 14 days | MEAN |
| SECONDARY | Postprandial Glycemia During Standardized Mixed Meal Consumption | 3 Hours Following Standardized Liquid Meal | Data were not collected for this outcome |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) | Avexitide 45 mg Twice Daily | Run-in period | 5.2 | Standard Deviation 3.52 | events per 14 days |
| Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) | Avexitide 90 mg Once Daily | Run-in period | 5.2 | Standard Deviation 3.52 | events per 14 days |
| Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) | Avexitide 45 mg Twice Daily | Treatment period | 2.7 | Standard Deviation 2.15 | events per 14 days |
| Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) | Avexitide 90 mg Once Daily | Treatment period | 2.1 | Standard Deviation 2.99 | events per 14 days |
| Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG | Avexitide 45 mg Twice Daily | Run-in period | 2.7 | Standard Deviation 3.1 | episodes per 14 days |
| Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG | Avexitide 90 mg Once Daily | Run-in period | 2.7 | Standard Deviation 3.1 | episodes per 14 days |
| Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG | Avexitide 45 mg Twice Daily | Treatment period | 1.2 | Standard Deviation 1.4 | episodes per 14 days |
| Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG | Avexitide 90 mg Once Daily | Treatment period | 1.3 | Standard Deviation 3.7 | episodes per 14 days |
| Rate of Level 3 Hypoglycemia | Avexitide 45 mg Twice Daily | Run-in period | 2.5 | Standard Deviation 3.1 | events per 14 days |
| Rate of Level 3 Hypoglycemia | Avexitide 90 mg Once Daily | Run-in period | 2.5 | Standard Deviation 3.1 | events per 14 days |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Period (14 Days) | STARTED | Run-in (All Participants) | 25 | |
| Run-in Period (14 Days) | STARTED | Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once Daily | 0 | |
| Run-in Period (14 Days) | STARTED | Avexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily | 0 | |
| Run-in Period (14 Days) | COMPLETED | Run-in (All Participants) | 25 | |
| Run-in Period (14 Days) | COMPLETED | Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once Daily | 0 | |
| Run-in Period (14 Days) | COMPLETED | Avexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily | 0 | |
| Run-in Period (14 Days) | NOT COMPLETED | Run-in (All Participants) | 0 | |
| Run-in Period (14 Days) | NOT COMPLETED | Avexitide 45 mg Twice Daily Then Avexitide 90 mg Once Daily | 0 | |
| Run-in Period (14 Days) | NOT COMPLETED | Avexitide 90 mg Once Daily Then Avexitide 45 mg Twice Daily | 0 | |
| Treatment Period 1 (14 Days) | STARTED | Run-in (All Participants) | 0 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | injection site bruising | Skin and subcutaneous tissue disorders | Run-in Period | 0 | 25 | 0 |
| other | injection site bruising | Skin and subcutaneous tissue disorders | Avexitide 45 mg Twice Daily | 6 | 17 | 6 |
| other | injection site bruising | Skin and subcutaneous tissue disorders | Avexitide 90 mg Once Daily | 8 | 17 | 8 |
| other | loose stools | Gastrointestinal disorders | Run-in Period | 0 | 25 | 0 |
| other | loose stools | Gastrointestinal disorders | Avexitide 45 mg Twice Daily | 5 | 17 | 5 |
| other | loose stools | Gastrointestinal disorders | Avexitide 90 mg Once Daily | 4 | 17 | 4 |
| other | headache | Nervous system disorders | Run-in Period | 0 | 25 | 0 |
| other | headache | Nervous system disorders | Avexitide 45 mg Twice Daily | 2 | 17 | 2 |
| other | headache | Nervous system disorders | Avexitide 90 mg Once Daily | 2 | 17 | 2 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Period | 0 | 25 |
| Total, all-cause mortality | Avexitide 45 mg Twice Daily | 0 | 17 |
| Total, all-cause mortality | Avexitide 90 mg Once Daily | 0 | 17 |
| Total, other adverse events | Run-in Period | 0 | 25 |
| Total, other adverse events | Avexitide 45 mg Twice Daily | 7 | 17 |
| Total, other adverse events | Avexitide 90 mg Once Daily | 8 | 17 |
| Total, serious adverse events | Run-in Period | 0 | 25 |
| Total, serious adverse events | Avexitide 45 mg Twice Daily | 0 | 17 |
| Total, serious adverse events | Avexitide 90 mg Once Daily | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42744082 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04652479
GET https://conductscience.org/api/trials/v1/NCT04652479/flow?page=2