Phase 2
N=9
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
Congenital Hyperinsulinism
Bottom Line
View on ClinicalTrials.gov: NCT00571324 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Mean Blood Glucose Area Under the Curve (AUC 0-6h) — 2,096; 1,678 mmol*min/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exendin-(9-39) (Drug); Vehicle (Other)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Diva De Leon
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Blood Glucose Area Under the Curve (AUC 0-6h) |
2,096; 1,678 | — |
| SECONDARY Mean Plasma Insulin Area Under the Curve (AUC 0-6h) |
21,016; 25,842 | — |
| SECONDARY Mean Plasma Glucagon Area Under the Curve (AUC 0-6h) |
21,243; 21,867 | — |
| SECONDARY Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h) |
1,970; 1,992 | — |
Summary
The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.
Eligibility Criteria
Inclusion Criteria
- Subjects with congenital hyperinsulinism
Exclusion Criteria
- Acute medical illness
- History of other systemic chronic disease such as cardiac failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension
- Pregnancy
- Diabetes mellitus
- Use of medications that affect glucose metabolism, such as glucocorticoids, beta agonists, diazoxide and octreotide.
- Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hrs after last dose of diazoxide
Data sourced from ClinicalTrials.gov (NCT00571324). 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.