GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

400

estimated

Study population

Type 1 diabetes, Type 2 diabetes

Key I/E criterion

•HbA1c 7-11%

Primary endpoints

•Clinical utility and safety of pramlintide (HbA1c, change, Postprandial glucose, Body weight, absolute change (kg), HOMA-IR (insulin sensitivity))•Understand management issues

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 IDNCT00108004

Org study ID137-155

Timeline

Milestones

Study first posted2005-04-13estimated

Last update posted2015-05-21estimated

Study start2003-04 (month precision)

Primary completion2005-06actual (month precision)

Study completion2005-06actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Type 1 diabetesType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening.

•The subject has a HbA1c of 7.0% to 11.0% at Screening.

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

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint/low confidence

To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus

Time frame:6 months

descriptive

componentsHbA1c, change, Postprandial glucose, Body weight, absolute change (kg), HOMA-IR (insulin sensitivity), Treatment-emergent AEs (any)

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Understand management issues in subjects with type 1 and type 2 diabetes mellitus

Time frame:6 months

descriptive

Publications (3)

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

Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy.
Postgraduate medicine2013 May (month)PMID23748514doi:10.3810/pgm.2013.05.2635via clinicaltrials gov reference derived + pubmed nct search
Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight.
Diabetes technology & therapeutics2007 Apr (month)PMID17425446doi:10.1089/dia.2006.0013via clinicaltrials gov reference derived + pubmed nct search
Pramlintide in the treatment of diabetes.
International journal of clinical practice2006 Dec (month)PMID17109671doi:10.1111/j.1742-1241.2006.01187.xvia clinicaltrials gov reference derived + pubmed nct search

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.