Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

NCTNCT00571324Other id2007-1-5131Other idR03DK078535-01

Open at ClinicalTrials.govAsk about this trial

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: 9 participants (actual)
Sponsor: Diva De Leon · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Aug 2007
Primary completion: Dec 2014
Completion: Dec 2014
First posted: 12 Dec 2007 (estimated)
Last update posted: 11 Dec 2017
Conditions: Congenital Hyperinsulinism

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2008201020122014

Ph 1/2
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
NCT00571324
Aug 2007 to Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Exendin-(9-39)Drug
VehicleOther

Arms2

Experimental
Exendin-(9-39) first, the Vehicle
Exendin-(9-39) will be administered intravenously (IV) after an overnight fast. Exendin-(9-39) will be infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. The following day, after another overnight fast, normal saline (control) vehicle infusion will be administered intravenously (IV) over 6 hours. During both infusions, blood glucose levels will be measured every 20 minutes.
Placebo comparator
Vehicle first, then Exendin-(9-39)
Normal saline vehicle infusion will be administered intravenously (IV) after an overnight fast. The infusion will be given over 6 hours. The following day, after another overnight fast, Exendin-(9-39) will be infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. During both infusions, blood glucose levels will be measured every 20 minutes.

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Blood Glucose Area Under the Curve (AUC 0-6h)
Time frame · 6 hours
Registry description
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 outcomes(3)

Mean Plasma Insulin Area Under the Curve (AUC 0-6h)
Time frame · 6 hours
Registry description
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.
Mean Plasma Glucagon Area Under the Curve (AUC 0-6h)
Time frame · 6 hours
Registry description
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.
Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h)
Time frame · 6 hours
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 hours

Mean Blood Glucose Area Under the Curve (AUC 0-6h)

Group	Value (mmol*min/L)	Spread
Exendin-(9-39)	2,096	454
Vehicle	1,678	281

Secondary and other outcome results(3)

Secondary outcomeMean· 6 hours

Mean Plasma Insulin Area Under the Curve (AUC 0-6h)

Group	Value (pmol*min/L)	Spread
Exendin-(9-39)	21,016	7,410
Vehicle	25,842	12,397

Secondary outcomeMean· 6 hours

Mean Plasma Glucagon Area Under the Curve (AUC 0-6h)

Group	Value (pg*min/dL)	Spread
Exendin-(9-39)	21,243	5,836
Vehicle	21,867	4,432

Secondary outcomeMean· 6 hours

Mean Plasma Intact Glucagon-Like Peptide-1 (GLP-1) Area Under the Curve (AUC 0-6h)

Group	Value (pmol*min/L)	Spread
Exendin-(9-39)	1,970	1,284
Vehicle	1,992	1,203

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exendin-(9-39)Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.	–	0 / 9	0 / 9
VehicleNormal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.	–	0 / 9	4 / 9

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.

DerivedCalabria AC, Li C, Gallagher PR, Stanley CA, De Leon DD. GLP-1 receptor antagonist exendin-(9-39) elevates fasting blood glucose levels in congenital hyperinsulinism owing to inactivating mutations in the ATP-sensitive K+ channel. Diabetes. 2012 Oct;61(10):2585-91. doi: 10.2337/db12-0166. Epub 2012 Aug 1. PMID 22855730

Eligibility

Who could join, as posted.

Sex: All
Age: from 7 Years up to 60 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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