Pramlintide in Adolescents With Type 1 Diabetes
Effects of Pramlintide in Adolescents With Type 1 Diabetes
1 other identifier
interventional
10
1 country
1
Brief Summary
The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes. This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
February 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
October 19, 2012
CompletedJune 23, 2015
September 1, 2012
3 years
January 20, 2009
September 17, 2012
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c Value After 28 Days
HbA1c values 28 days after randomization
28
Secondary Outcomes (1)
Weight Change After 28 Days Intervention Period
28 days
Study Arms (2)
1 Symlin
EXPERIMENTALSubcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
2 Usual Regimen
NO INTERVENTIONUsual bolus insulin dose at each meal
Interventions
subcutaneous injection (15 mcg initial dose)prior to meals
Eligibility Criteria
You may qualify if:
- Between 13 and 17 years of age, inclusive
- Diagnosed with type 1 diabetes for \> 1 year
- Hemoglobin A1c between 7.5 and 10% inclusive
- Currently using carbohydrate to insulin ratio
- Acceptable form of birth control
You may not qualify if:
- Use of oral hyperglycemic agents or medications affecting blood sugar levels
- Recurrent severe hypoglycemia requiring assistance in past 6 months
- History of hypoglycemia unawareness
- History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility
- Previous use of pramlintide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Amylin Pharmaceuticals, LLC.collaborator
Study Sites (1)
Barbara Davis Center
Aurora, Colorado, 80010, United States
Related Publications (1)
Kishiyama CM, Burdick PL, Cobry EC, Gage VL, Messer LH, McFann K, Chase HP. A pilot trial of pramlintide home usage in adolescents with type 1 diabetes. Pediatrics. 2009 Nov;124(5):1344-7. doi: 10.1542/peds.2008-3750. Epub 2009 Oct 26.
PMID: 19858155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. H. Peter Chase
- Organization
- UColorado
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Chase, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2009
First Posted
February 12, 2009
Study Start
December 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 23, 2015
Results First Posted
October 19, 2012
Record last verified: 2012-09