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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be the first evaluation of Symlin in adolescent subjects with type 1 diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics), biochemical and physiological effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Islet Amyloid Polypeptide; Pramlintide

Criteria

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