Phase 2
N=16
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
Congenital Hyperinsulinism
Bottom Line
View on ClinicalTrials.gov: NCT00897676 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Area Under the Curve (AUC) Plasma Glucose — 26994.7; 32122.2 mg*min/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exendin-(9-39) (Drug); placebo (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Diva De Leon
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) Plasma Glucose |
26994.7; 32122.2 | — |
| SECONDARY Area Under the Curve (AUC) Plasma Insulin |
1578.7; 1284.5 | — |
| SECONDARY Area Under the Curve (AUC) Plasma C-peptide |
281.4; 236.6 | — |
| SECONDARY Area Under the Curve (AUC) Plasma Glucagon |
22806.8; 23409.4 | — |
| SECONDARY Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1) |
4899.3; 5698.8 | — |
| SECONDARY Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1) |
1373.7; 1432.9 | — |
Summary
The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding Source - FDA Office of Orphan Products Development (OODP).
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of hyperinsulinism
- Mutation analysis results demonstrating KATP channel defect
- Age 6 months to 18 years with
- Persistent hypoglycemia
Exclusion Criteria
- Current therapy with medications that may affect glucose metabolism such as octreotide, diazoxide, high dose glucocorticoids, adrenergic agents, etc. Subjects will be eligible to participate if the last dose of octreotide is given 48 hrs before study day 1 and the last dose of diazoxide is given 72 hours before study day 1
- Evidence of a medical condition that might alter results or compromised the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
- Pregnancy
- Subjects with milk protein allergy will be excluded for participating in studies involving protein tolerance test
Data sourced from ClinicalTrials.gov (NCT00897676). 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.