DelfaGLP-1 Atlas

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Exenatide

Terminated

Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy

Lead sponsor

AstraZeneca

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

7

actual

Study population

Type 2 diabetes

Key I/E criterion

•Female

Primary endpoint

•Primary Outcome

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 IDNCT00579150
Org study IDD5550C00004
Secondary IDBCA401INC Research

Timeline

Milestones

Study first posted2007-12-21estimated
Last update posted2016-05-25estimated
Study start2009-01 (month precision)
Primary completion2016-04actual (month precision)
Study completion2016-04actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexFemale
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Is pregnant and at least 18 years of age at the time of enrollment

Eligibility criteria

The subjects must meet the following eligibility criteria for participation in the registry:

•Is pregnant and at least 18 years of age at the time of enrollment
•Had a diagnosis of type 2 diabetes prior to pregnancy
•Does not know the pregnancy outcome at the time of enrollment
•Has no knowledge of any existing structural or chromosomal defects detected on a prenatal test prior to enrollment
•Had been exposed to an immediate release formulation of exenatide (e.g. BYETTA®) or a non-insulin antidiabetic medication other than exenatide on or after the first day of the last menstrual period (insulin use will be allowed for both groups). OR participant has been exposed to an extended release formulation of exenatide (e.g. BYDUREON®) within 8 weeks of the first day of the last menstrual period
•Is willing and able to provide informed consent and an authorization for the pregnancy registry to contact the obstetric HCP, diabetes HCP, and the infant's pediatric HCP (and complete contact information for these practitioners, if different, and if available)
•Is able to understand spoken English or Spanish

Endpoints (2)

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
1
Other clinical outcomes
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Primary Outcome

Time frame:For each group, primary outcome measure will be assessed among all births, including major birth defects identified during the postnatal period and up to infant age 12 months.

threshold achievement, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Secondary Outcome Measure

Time frame:For each group, secondary outcome measures will be assessed among all identified pregnancies.

composite event, event

componentsrecognized spontaneous abortion, stillbirth, preterm birth, infant macrosomia, low birth weight, infant growth first 4 months breastfeeding impact

Publications (10)

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.