Status:
COMPLETED
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Lead Sponsor:
AstraZeneca
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief 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 ef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00313183
Start Date
April 1 2006
End Date
August 1 2007
Last Update
March 6 2015
Active Locations (3)
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1
Research Site
Aurora, Colorado, United States
2
Research Site
Kansas City, Missouri, United States
3
Research Site
New York, New York, United States