DelfaGLP-1 Atlas

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CompletedPhase 3

Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

A Multicenter, Open-Label, Extension Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completing Protocol 137-150

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

25

Recruiting sites

—

Enrollment

190

actual

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoints

•Long term safety profile of pramlintide treatment•Long-term effect of subcutaneously (SC) injected pramlintide on body weight

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 IDNCT00107107
Org study ID137-150E

Timeline

Milestones

Study first posted2005-04-06estimated
Last update posted2015-09-23estimated
Study start2002-11 (month precision)
Primary completion2005-06actual (month precision)
Study completion2005-06actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

•The subject has completed the full dosing period in Protocol 137-150.

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

Weight & body composition
1
Glycemic / diabetes
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight

Time frame:participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.

Time frame:participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150.

Time frame:participant will be followed for the duration of the study, an average of 6 months or until Pramlintide is commercially available

descriptive

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.