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CompletedPhase NAResults posted

Pramlintide in Adolescents With Type 1 Diabetes

Effects of Pramlintide in Adolescents With Type 1 Diabetes

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

1

Recruiting sites

Enrollment

10

actual

Study population

Type 1 diabetes

Key I/E criteria

HbA1c 7.5-10%Age 13-17

Primary endpoint

HbA1c Value After 28 Days

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 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

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

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
1
Glycemic / diabetes
1

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

GroupValue (mean), kg95% CI
1 Symlin-0.84
2 Usual Regimen0.04

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

HbA1c Value After 28 Days

Time frame:28

descriptive, improvement

LOINC 4548-4

Posted result

GroupValue (mean), HbA1c %95% CI
1 Symlin7.94
2 Usual Regimen8.72

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.