Back to resultsA Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pramlintide acetate
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes, pediatric, pramlintide, Symlin, Amylin
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
Outcomes
Primary Outcome Measures
To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes
To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes
Secondary Outcome Measures
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00313183
Brief Title
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes, pediatric, pramlintide, Symlin, Amylin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
Intervention Type
Drug
Intervention Name(s)
pramlintide acetate
Other Intervention Name(s)
Symlin
Intervention Description
single subcutaneous doses of 15mcg and 30mcg
Primary Outcome Measure Information:
Title
To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes
Time Frame
single doses
Title
To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes
Time Frame
single doses
Secondary Outcome Measure Information:
Title
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
Time Frame
single doses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Porter, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
12. IPD Sharing Statement
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A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
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