DelfaGLP-1 Atlas

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CompletedPhase 2

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

5

Recruiting sites

—

Enrollment

13

actual

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c 6-11%•Age 10-16

Primary endpoints

•Pharmacokinetics of exenatide•Pharmacodynamics of exenatide (Postprandial glucose, C-peptide AUC)•Treatment-emergent AEs (any)

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 IDNCT00254254
Org study ID2993-124

Timeline

Milestones

Study first posted2005-11-16estimated
Last update posted2015-02-23estimated
Study start2006-02 (month precision)
Primary completion2007-02actual (month precision)
Study completion2007-02actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years
Maximum age16 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months.
•Has HbA1c 6.0% to 11.0%, inclusive, at screening.
•Has a body weight of >= 50 kg at screening.

Exclusion criteria

•Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
•Currently participates in any other interventional study.
•Is currently treated with any of the following excluded medications:
–Sulfonylurea chlorpropamide
–Thiazolidinedione within 3 months of screening.
–Αlpha glucosidase inhibitor within 3 months of screening.
–Meglitinide within 3 months of screening.
–Insulin within 3 months of screening.
–Pramlintide within 3 months of screening.

Endpoints (3)

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

Safety / tolerability / PK
2
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint/low confidence

To assess the pharmacodynamics of exenatide

Time frame:Three day-long (8 hour) assessments over a 5-week period

descriptive

componentsPostprandial glucose, C-peptide AUC

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

To assess the pharmacokinetics of exenatide

Time frame:Three day-long (8 hour) assessments over a 5-week period

descriptive

Primary/protocol endpoint

Number of adverse events

Time frame:Visit 2 through Visit 4

Treatment-emergent AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.