CompletedPhase 2

A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SYMLIN in Adolescent Subjects With Type 1 Diabetes Mellitus

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

•HbA1c 6-10%•Age 12-17

Primary endpoints

•Pharmacokinetics of Symlin•Safety and tolerability of Symlin

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 IDNCT00313183

Org study ID137-162

Timeline

Milestones

Study first posted2006-04-12estimated

Last update posted2015-03-06estimated

Study start2006-04 (month precision)

Primary completion2007-08actual (month precision)

Study completion2007-08actual (month precision)

Assets

Investigational agents

Pramlintide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening

•Be on a stable regimen requiring multiple daily injections of basal and mealtime insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to screening

•HbA1c between 6.0% and 10.0%, inclusive, at screening

•Body weight >=50 kg at screening

Exclusion criteria

•Currently being treated with the following medications: *Any oral antihyperglycemic agent; *Drugs that directly affect gastrointestinal motility

•Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)

•Has received any investigational drug within 1 month of screening

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

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes

Time frame:single doses

descriptive

Primary/protocol endpoint

To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes

Time frame:single doses

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints

Time frame:single doses

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.