Primary outcomeMean· Time 0 min - time 360 min
Area Under the Curve (AUC) Plasma Glucose
| Group | Value (mg*min/dL) | Spread |
|---|---|---|
| Vehicle | 26994.7 | 4219.8 |
| Exendin-(9-39) | 32122.2 | 6650.1 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataEffect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
This trial does not test a peptide that PepBank tracks.
- Measures Glucagon, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Phase 1/2
- Enrollment
- 17 participants (actual)
- Sponsor
- Diva De Leon · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- May 2009
- Primary completion
- 26 Aug 2016
- Completion
- Jan 2017
- First posted
- 12 May 2009 (estimated)
- Last update posted
- 13 Mar 2020
- Conditions
- Congenital Hyperinsulinism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20102012201420162018
- Ph 1/2
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
NCT00897676May 2009 to Jan 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- Exendin-(9-39)Drug
- placeboDrug
Arms2
Other
Vehicle first, then Exendin-(9-39)
An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). At time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. The following day, at time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, GLP-1, and glucagon will be measured every 30 minutes.
Other
Exendin-(9-39) first then Vehicle.
An infusion of vehicle (0.9%NaCl) will run for 60 minutes(time -60 to 0) before starting the study infusion of vehicle or exendin-(9-39). . At time 0, exendin-(9-39) at a dose ranging from 100-500pmol/kg/min will be started and continue for 6 hours. The following day, at time 0, vehicle (0.9%NaCl) will be started and will continue for 6 hours. During both infusions, blood glucose, insulin, c-peptide, GLP-1, and glucagon will be measured every 30 minutes. .
Primary outcomes1
Outcomes the sponsor listed as primary.
Area Under the Curve (AUC) Plasma Glucose
Time frame · Time 0 min - time 360 min
Registry description
Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion
Secondary outcomes(5)
Area Under the Curve (AUC) Plasma Insulin
Time frame · time 0 min to time 360 min
Registry description
Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion
Area Under the Curve (AUC) Plasma C-peptide
Time frame · time 0 min to time 360 min
Registry description
Area under the curve plasma C-peptide from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion
Area Under the Curve (AUC) Plasma Glucagon
Time frame · time 0 min to time 360 min
Registry description
Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion
Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1)
Time frame · time 0 to time 360 min
Registry description
Area under the curve plasma total GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion
Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1)
Time frame · time 0 min to time 360 min
Registry description
Area under the curve plasma active GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeMean· time 0 min to time 360 min
Area Under the Curve (AUC) Plasma Insulin
| Group | Value (uIU*min/mL) | Spread |
|---|---|---|
| Vehicle | 1578.7 | 1089.9 |
| Exendin-(9-39) | 1284.5 | 553.7 |
Secondary outcomeMean· time 0 min to time 360 min
Area Under the Curve (AUC) Plasma C-peptide
| Group | Value (ng*min/mL) | Spread |
|---|---|---|
| Vehicle | 281.4 | 155.8 |
| Exendin-(9-39) | 236.6 | 112.5 |
Secondary outcomeMean· time 0 min to time 360 min
Area Under the Curve (AUC) Plasma Glucagon
| Group | Value (pg*min/mL) | Spread |
|---|---|---|
| Vehicle | 22806.8 | 10210.3 |
| Exendin-(9-39) | 23409.4 | 11396.1 |
Secondary outcomeMean· time 0 to time 360 min
Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1)
| Group | Value (pmol*min/L) | Spread |
|---|---|---|
| Vehicle | 4899.3 | 2598.8 |
| Exendin-(9-39) | 5698.8 | 3484.8 |
Secondary outcomeMean· time 0 min to time 360 min
Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1)
| Group | Value (pmol*min/L) | Spread |
|---|---|---|
| Vehicle | 1373.7 | 1044 |
| Exendin-(9-39) | 1432.9 | 1114.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| VehicleSubjects received an infusion of vehicle (0.9% NaCl) intravenously from time 0 min to time 360 min Vehicle: (0.9% NaCl) | 0 / 16 | 0 / 16 | 12 / 16 |
| Exendin-(9-39)Subjects received an infusion of exendin-(9-39) intravenously at a dose ranging from 100-500pmol/kg/min from time 0 min to time 360 min Exendin-(9-39) | 0 / 16 | 0 / 16 | 8 / 16 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedStefanovski D, Vajravelu ME, Givler S, De Leon DD. Exendin-(9-39) Effects on Glucose and Insulin in Children With Congenital Hyperinsulinism During Fasting and During a Meal and a Protein Challenge. Diabetes Care. 2022 Jun 2;45(6):1381-1390. doi: 10.2337/dc21-2009. PMID 35416981
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 6 Months up to 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
PepBank is a research reference. Talk to a doctor before you use any peptide.