A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
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
1 other identifier
interventional
12
1 country
3
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 effects (pharmacodynamics), and safety and tolerability of Symlin in these subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2006
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 10, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMarch 6, 2015
January 1, 2015
1.3 years
April 10, 2006
March 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes
single doses
To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes
single doses
Secondary Outcomes (1)
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
single doses
Study Arms (1)
1
EXPERIMENTALsingle doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Aurora, Colorado, United States
Research Site
Kansas City, Missouri, United States
Research Site
New York, New York, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2006
First Posted
April 12, 2006
Study Start
April 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
March 6, 2015
Record last verified: 2015-01