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

Completed · Phase 2

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00313183

Run by

AstraZeneca

People needed

12

Starts

2006-04-01

Expected to finish

2007-08-01

Last updated by the study team

2015-03-06

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Aurora, Colorado, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — New York, New York, United States

Full record on ClinicalTrials.gov

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