Trial · NCT00571324
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
NCT00571324, Phase 1, Phase 2, Completed, Diva De Leon; results first posted 2016-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism. Trials, record NCT00571324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00571324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
- NCT number
- NCT00571324
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Diva De Leon
- Conditions
- Congenital Hyperinsulinism
- Interventions
- Exendin-(9-39), Vehicle
- First posted
- 2007-12-12
- Last updated
- 2017-12-11
- Results first posted
- 2016-11-09
- Limitations and caveats
- Due to safety concerns subjects with symptomatic hypoglycemia were rescued with dextrose to maintain glucose levels \>60mg/dL limiting detectable treatment effect.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Blood Glucose Area Under the Curve (AUC 0-6h) | 6 hours | To examine the effect of Exendin-(9-39) on fasting blood glucose levels, samples were collected at various time points before and during the infusion \[Exendin-(9-39) or vehicle\] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean blood glucose area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared. |
| Secondary | Mean Plasma Insulin Area Under the Curve (AUC 0-6h) | 6 hours | To examine the effect of Exendin-(9-39) on plasma insulin levels, samples were collected at various time points before and during the infusion \[Exendin-(9-39) or vehicle\] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma insulin area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared. |
| Secondary | Mean Plasma Glucagon Area Under the Curve (AUC 0-6h) | 6 hours | To examine the effect of Exendin-(9-39) on plasma glucagon levels, samples were collected at various time points before and during the infusion \[Exendin-(9-39) or vehicle\] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean plasma glucagon area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared. |
| Secondary | Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h) | 6 hours | To examine the effect of Exendin-(9-39) on plasma intact glucagon-like Peptide-1 (GLP-1) levels, samples were collected at various time points before and during the infusion \[Exendin-(9-39) or vehicle\] including: 60 minutes before the start of the infusion, again at the start of the infusion (Time 0), and then every 20 minutes until 6 hours after the start of the infusion. Using this information, the mean intact GLP-1 area under the curve (AUC) from the start of the infusion to the end of the infusion (360 minutes) was calculated for each both Exendin-(9-39) and vehicle and compared. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Blood Glucose Area Under the Curve (AUC 0-6h) | 6 hours | Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle. | mmol*min/L | MEAN |
| SECONDARY | Mean Plasma Insulin Area Under the Curve (AUC 0-6h) | 6 hours | Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle. | pmol*min/L | MEAN |
| SECONDARY | Mean Plasma Glucagon Area Under the Curve (AUC 0-6h) | 6 hours | Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle. | pg*min/dL | MEAN |
| SECONDARY | Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h) | 6 hours | Subjects served as their own control for comparison between effects of Exendin-(9-39) and the normal saline vehicle. | pmol*min/L | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Blood Glucose Area Under the Curve (AUC 0-6h) | Exendin-(9-39) | 2,096 | Standard Error 454 | mmol*min/L | |
| Mean Blood Glucose Area Under the Curve (AUC 0-6h) | Vehicle | 1,678 | Standard Error 281 | mmol*min/L | |
| Mean Plasma Insulin Area Under the Curve (AUC 0-6h) | Exendin-(9-39) | 21,016 | Standard Error 7,410 | pmol*min/L | |
| Mean Plasma Insulin Area Under the Curve (AUC 0-6h) | Vehicle | 25,842 | Standard Error 12,397 | pmol*min/L | |
| Mean Plasma Glucagon Area Under the Curve (AUC 0-6h) | Exendin-(9-39) | 21,243 | Standard Error 5,836 | pg*min/dL | |
| Mean Plasma Glucagon Area Under the Curve (AUC 0-6h) | Vehicle | 21,867 | Standard Error 4,432 | pg*min/dL | |
| Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h) | Exendin-(9-39) | 1,970 | Standard Error 1,284 | pmol*min/L | |
| Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h) | Vehicle | 1,992 | Standard Error 1,203 | pmol*min/L |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention 1 (7 Hours) | STARTED | Exendin-(9-39) First, the Vehicle | 5 | |
| Intervention 1 (7 Hours) | STARTED | Vehicle First, Then Exendin-(9-39) | 4 | |
| Intervention 1 (7 Hours) | COMPLETED | Exendin-(9-39) First, the Vehicle | 5 | |
| Intervention 1 (7 Hours) | COMPLETED | Vehicle First, Then Exendin-(9-39) | 4 | |
| Intervention 1 (7 Hours) | NOT COMPLETED | Exendin-(9-39) First, the Vehicle | 0 | |
| Intervention 1 (7 Hours) | NOT COMPLETED | Vehicle First, Then Exendin-(9-39) | 0 | |
| Intervention 2 (7 Hours) | STARTED | Exendin-(9-39) First, the Vehicle | 5 | |
| Intervention 2 (7 Hours) | STARTED | Vehicle First, Then Exendin-(9-39) | 4 | |
| Intervention 2 (7 Hours) | COMPLETED | Exendin-(9-39) First, the Vehicle | 5 | |
| Intervention 2 (7 Hours) | COMPLETED | Vehicle First, Then Exendin-(9-39) | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
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 | Hypoglycemia | Endocrine disorders | Exendin-(9-39) | 0 | 9 | 0 |
| other | Hypoglycemia | Endocrine disorders | Vehicle | 3 | 9 | 3 |
| other | Headache | General disorders | Exendin-(9-39) | 0 | 9 | 0 |
| other | Headache | General disorders | Vehicle | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exendin-(9-39) | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | Exendin-(9-39) | 0 | 9 |
| Total, other adverse events | Vehicle | 4 | 9 |
| Total, serious adverse events | Exendin-(9-39) | 0 | 9 |
| Total, serious adverse events | Vehicle | 0 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22855730 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R03DK078535 | Effect of exendin-(9-39) on glucose metabolism in subjects with hyperinsulinism | DE LEON, DIVA D. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2007 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Exendin-(9-39) vs Vehicle: serious adverse events |
Source Trial comparisons
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/NCT00571324
GET https://conductscience.org/api/trials/v1/NCT00571324/registered