Trial · NCT00835328
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
NCT00835328, Phase 1, Phase 2, Terminated, Diva De Leon; results first posted 2020-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia. Trials, record NCT00835328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
- NCT number
- NCT00835328
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Diva De Leon
- Conditions
- Congenital Hyperinsulinism
- Interventions
- Exendin (9-39), Vehicle
- First posted
- 2009-02-03
- Last updated
- 2020-06-01
- Results first posted
- 2020-05-14
- Limitations and caveats
- The trial was terminated after 14 participants enrolled in the study. No data is available for any outcome measures.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Glucose Infusion Rate (GIR) | Up to 9 hours after the initiation of infusion | To assess the effect of Exendin (9-39) on glucose infusion rate, glucose infusion rate (GIR) over the last 2 hours of the treatment period was calculated by adding the total amount of intravenous glucose (mg) received over 2 hours divided by the weight (kg) and by time (120 min) during infusion of Exendin (9-39) and normal saline vehicle. |
| Primary | To Determine the Pharmacokinetics of Exendin (9-39) | Up to 12 hours after the initiation of infusion | The following PK variables of interest include AUC0-∞, AUC0-t, maximal concentration (Cmax), time to maximal concentration (Tmax), concentration at end of infusion (Ceoi), steady state volume of distribution (Vss), clearance (CL) and half-life (t1/2) of Exendin (9-39). These will be derived through both non-compartmental and model-based methods. |
| Secondary | Safety and Tolerability of Exendin (9-39) | Up to 24 hours post-infusion | Number of participants with adverse events as a measure of safety and tolerability \[evaluated by the result of laboratory safety tests (hematology, chemistry, urinalysis), vital signs, physical examinations, and 12-lead ECG\] |
| Secondary | Mean Plasma Insulin | Up to 9 hours after the initiation of infusion | To assess the effect of Exendin (9-39) on plasma insulin levels, samples were collected at various time points during the infusion \[Exendin (9-39) or vehicle\] including: at the start of the infusion (T=0) and at 1, 5, and 9 hours post initiation of the infusion. |
| Secondary | Mean Plasma Glucose | Up to 9 hours after the initiation of infusion | To assess the effect of Exendin (9-39) on plasma glucose levels, samples were collected at various time points during the infusion \[Exendin (9-39) or vehicle\] including: at the start of the infusion (T=0) and at 1, 5, and 9 hours post initiation of the infusion. |
| Secondary | Mean Betahydroxybutyrate Levels | Up to 12 hours after the initiation of infusion | To assess the effect of Exendin (9-39) on mean betahydroxybutyrate levels, samples were collected at various time points during the infusion \[Exendin (9-39) or vehicle\] including: at the start of the infusion (T=0) and hourly up to 12-hours post initiation of the infusion. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Glucose Infusion Rate (GIR) | Up to 9 hours after the initiation of infusion | Subjects served as their own control for comparison between the effects of Exendin (9-39) and the normal saline vehicle. The trial was terminated after 14 participants enrolled in the study. No data is available for any outcome measures. | ||
| PRIMARY | To Determine the Pharmacokinetics of Exendin (9-39) | Up to 12 hours after the initiation of infusion | Subjects served as their own control for comparison between the effects of Exendin (9-39) and the normal saline vehicle. The trial was terminated after 14 participants enrolled in the study. No data is available for any outcome measures. | ||
| SECONDARY | Safety and Tolerability of Exendin (9-39) | Up to 24 hours post-infusion | Subjects served as their own control for comparison between the effects of Exendin (9-39) and the normal saline vehicle. The trial was terminated after 14 participants enrolled in the study. No data is available for any outcome measures. | ||
| SECONDARY | Mean Plasma Insulin | Up to 9 hours after the initiation of infusion | Subjects served as their own control for comparison between the effects of Exendin (9-39) and the normal saline vehicle. The trial was terminated after 14 participants enrolled in the study. No data is available for any outcome measures. | ||
| SECONDARY | Mean Plasma Glucose | Up to 9 hours after the initiation of infusion | Subjects served as their own control for comparison between the effects of Exendin (9-39) and the normal saline vehicle. The trial was terminated after 14 participants enrolled in the study. No data is available for any outcome measures. | ||
| SECONDARY | Mean Betahydroxybutyrate Levels | Up to 12 hours after the initiation of infusion | Subjects served as their own control for comparison between the effects of Exendin (9-39) and the normal saline vehicle. The trial was terminated after 14 participants enrolled in the study. No data is available for any outcome measures. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort 1: Dose Level 1 | STARTED | Exendin (9-39) 0.02 mg/kg/hr | 5 | |
| Cohort 1: Dose Level 1 | STARTED | Exendin (9-39) 0.04 mg/kg/hr | 0 | |
| Cohort 1: Dose Level 1 | STARTED | Exendin (9-39) 0.10 mg/kg/hr | 0 | |
| Cohort 1: Dose Level 1 | STARTED | Exendin (9-39) 0.20 mg/kg/hr | 0 | |
| Cohort 1: Dose Level 1 | COMPLETED | Exendin (9-39) 0.02 mg/kg/hr | 5 | |
| Cohort 1: Dose Level 1 | COMPLETED | Exendin (9-39) 0.04 mg/kg/hr | 0 | |
| Cohort 1: Dose Level 1 | COMPLETED | Exendin (9-39) 0.10 mg/kg/hr | 0 | |
| Cohort 1: Dose Level 1 | COMPLETED | Exendin (9-39) 0.20 mg/kg/hr | 0 | |
| Cohort 1: Dose Level 1 | NOT COMPLETED | Exendin (9-39) 0.02 mg/kg/hr | 0 | |
| Cohort 1: Dose Level 1 | NOT COMPLETED | Exendin (9-39) 0.04 mg/kg/hr | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events20
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 | Emesis | Gastrointestinal disorders | Exendin (9-39) 0.02 mg/kg/hr | 0 | 5 | 0 |
| other | Emesis | Gastrointestinal disorders | Exendin (9-39) 0.04 mg/kg/hr | 0 | 2 | 0 |
| other | Emesis | Gastrointestinal disorders | Exendin (9-39) 0.10 mg/kg/hr | 1 | 2 | 1 |
| other | Emesis | Gastrointestinal disorders | Exendin (9-39) 0.20 mg/kg/hr | 1 | 4 | 1 |
| other | Emesis | Gastrointestinal disorders | Vehicle | 2 | 13 | 2 |
| other | Hyperglycemia | Endocrine disorders | Exendin (9-39) 0.02 mg/kg/hr | 0 | 5 | 0 |
| other | Hyperglycemia | Endocrine disorders | Exendin (9-39) 0.04 mg/kg/hr | 0 | 2 | 0 |
| other | Hyperglycemia | Endocrine disorders | Exendin (9-39) 0.10 mg/kg/hr | 1 | 2 | 1 |
| other | Hyperglycemia | Endocrine disorders | Exendin (9-39) 0.20 mg/kg/hr | 0 | 4 | 0 |
| other | Hyperglycemia | Endocrine disorders | Vehicle | 0 | 13 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exendin (9-39) 0.02 mg/kg/hr | 0 | 5 |
| Total, all-cause mortality | Exendin (9-39) 0.04 mg/kg/hr | 0 | 2 |
| Total, all-cause mortality | Exendin (9-39) 0.10 mg/kg/hr | 0 | 2 |
| Total, all-cause mortality | Exendin (9-39) 0.20 mg/kg/hr | 0 | 4 |
| Total, all-cause mortality | Vehicle | 0 | 13 |
| Total, other adverse events | Exendin (9-39) 0.02 mg/kg/hr | 1 | 5 |
| Total, other adverse events | Exendin (9-39) 0.04 mg/kg/hr | 2 | 2 |
| Total, other adverse events | Exendin (9-39) 0.10 mg/kg/hr | 2 | 2 |
| Total, other adverse events | Exendin (9-39) 0.20 mg/kg/hr | 4 | 4 |
| Total, other adverse events | Vehicle | 10 | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00835328
GET https://conductscience.org/api/trials/v1/NCT00835328/flow?page=2