A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
NCT ID: NCT00313183
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2006-04-30
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg
Interventions
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pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Aurora, Colorado, United States
Research Site
Kansas City, Missouri, United States
Research Site
New York, New York, United States
Countries
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Other Identifiers
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137-162
Identifier Type: -
Identifier Source: org_study_id
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