GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy

Lead sponsor

AstraZeneca

Asset

Pramlintide

Amylin analog

Listed sites

Recruiting sites

—

Enrollment

296

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c 7.5-9%

Primary endpoint

•- To investigate the safety of pramlintide treatment employing dose titration

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 IDNCT00042458

Org study ID137-150

Timeline

Milestones

Study first posted2002-08-01estimated

Last update posted2015-09-23estimated

Study start2002-04 (month precision)

Primary completion2003-03actual (month precision)

Study completion2003-03actual (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

•HbA1c value between 7.5-9%

•Using multiple daily insulin injections

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

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.

Time frame:29 Weeks

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.

Time frame:29 Weeks

change from baseline, improvement

componentsHbA1c, change, Postprandial glucose, Body weight, absolute change (kg)

Secondary/protocol endpoint/low confidence

- To examine the pattern of daily insulin use over the course of the study.

Time frame:29 Weeks

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

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

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.