Phase 2
N=25
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
Acquired Hyperinsulinemic Hypoglycemia
Bottom Line
View on ClinicalTrials.gov: NCT04652479 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) — 5.2; 5.2; 2.7; 2.1 events per 14 days — p=0.0028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Avexitide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dr. Tracey McLaughlin, MD
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) |
5.2; 5.2; 2.7; 2.1 | 0.0028 sig |
| SECONDARY Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG |
2.7; 2.7; 1.2; 1.3 | 0.0027 sig |
| SECONDARY Rate of Level 3 Hypoglycemia |
2.5; 2.5; 0.8; 0.9 | 0.0003 sig |
| SECONDARY Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time) |
1.50; 1.50; 0.96; 0.48 | 0.161 |
| SECONDARY Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time) |
4.20; 4.20; 2.86; 1.96 | 0.145 |
| SECONDARY Postprandial Glycemia During Standardized Mixed Meal Consumption |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04652479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.