DelfaGLP-1 Atlas

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TerminatedPhase 1, PHASE2Results posted

Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia

Role of Glucagon-Like Peptide-1 (GLP-1) in Congenital Hyperinsulinism: Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia

Lead sponsor

Diva De Leon

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

14

actual

Study population

Prediabetes / glucose intolerance

Key I/E criterion

•Age ≤12

Primary endpoints

•Mean Glucose Infusion Rate (GIR)•Pharmacokinetics of Exendin (9-39)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00835328
Org study ID2008-10-6256

Timeline

Milestones

Study first posted2009-02-03estimated
Study start2009-08-26actual
Primary completion2017-01-28actual
Study completion2017-01-28actual
Results first posted2020-05-14actual
Last update posted2020-06-01actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Prediabetes / glucose intolerance

Eligibility

Who can enroll

Maximum age12 Months
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Confirmed clinical diagnosis of congenital hyperinsulinism

2. Infants less than 12 months of age at study enrollment

3. Failure to respond to treatment with diazoxide

Exclusion criteria

1. Evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure

2. Treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including:

1. Treatment with glucagon 4 hours prior to infusion (T=0)

2. Treatment with octreotide 24 hours prior to infusion (T=0)

3. Treatment with diazoxide 72 hours prior to infusion (T=0)

3. Suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
3
Safety / tolerability / PK
2
Other (unclassified)
1

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Mean Glucose Infusion Rate (GIR)

Time frame:Up to 9 hours after the initiation of infusion

descriptive

Secondary/protocol endpoint

Mean Plasma Insulin

Time frame:Up to 9 hours after the initiation of infusion

concentration, descriptive

Secondary/protocol endpoint

Mean Plasma Glucose

Time frame:Up to 9 hours after the initiation of infusion

descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

To Determine the Pharmacokinetics of Exendin (9-39)

Time frame:Up to 12 hours after the initiation of infusion

concentration, descriptive

Secondary/protocol endpoint

Safety and Tolerability of Exendin (9-39)

Time frame:Up to 24 hours post-infusion

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Mean Betahydroxybutyrate Levels

Time frame:Up to 12 hours after the initiation of infusion

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.