CompletedPhase NAResults posted

Pramlintide in Adolescents With Type 1 Diabetes

Effects of Pramlintide in Adolescents With Type 1 Diabetes

Lead sponsor

University of Colorado, Denver

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

•HbA1c 7.5-10%•Age 13-17

Primary endpoint

•HbA1c Value After 28 Days

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00842075

Org study ID05-0724(2)

Timeline

Milestones

Study first posted2009-02-12estimated

Results first posted2012-10-19estimated

Last update posted2015-06-23estimated

Study start2006-12 (month precision)

Primary completion2009-12actual (month precision)

Study completion2009-12actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age13 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Between 13 and 17 years of age, inclusive

•Diagnosed with type 1 diabetes for > 1 year

•Hemoglobin A1c between 7.5 and 10% inclusive

•Currently using carbohydrate to insulin ratio

•Acceptable form of birth control

Exclusion criteria

•Use of oral hyperglycemic agents or medications affecting blood sugar levels

•Recurrent severe hypoglycemia requiring assistance in past 6 months

•History of hypoglycemia unawareness

•History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility

•Previous use of pramlintide

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

Weight & body composition

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Weight Change After 28 Days Intervention Period

Time frame:28 days

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · kg	95% CI
1 Symlin	-0.84	-
2 Usual Regimen	0.04	-

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

HbA1c Value After 28 Days

Time frame:28

descriptive, improvement

LOINC 4548-4

Posted result

Group	Mean · HbA1c %	95% CI
1 Symlin	7.94	-
2 Usual Regimen	8.72	-

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

A pilot trial of pramlintide home usage in adolescents with type 1 diabetes.
Pediatrics2009 Nov (month)PMID19858155doi:10.1542/peds.2008-3750via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 6, 2026 snapshot.