A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Study identifier:137-162
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Type 1 Diabetes Mellitus
Phase
Phase 2
Healthy volunteers
No
Study drug
pramlintide acetate
Sex
All
Actual Enrollment
12
Study type
Interventional
Age
12 Years - 17 Years
Date
Study Start Date: 01 Apr 2006
Primary Completion Date: 01 Aug 2007
Study Completion Date: 01 Aug 2007
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects | Drug: pramlintide acetate single subcutaneous doses of 15mcg and 30mcg Other Name: Symlin |
Contacts
Investigators
Principal Investigator
Lisa Porter
Amylin Pharmaceuticals
