Pramlintide in Adolescents With Type 1 Diabetes
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Effects of Pramlintide in Adolescents With Type 1 Diabetes|
- HbA1c Value After 28 Days [ Time Frame: 28 ] [ Designated as safety issue: No ]HbA1c values 28 days after randomization
- Weight Change After 28 Days Intervention Period [ Time Frame: 28 days ] [ Designated as safety issue: No ]Mean weight change after 28 days intervention period
|Study Start Date:||December 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: 1 Symlin
Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
subcutaneous injection (15 mcg initial dose)prior to meals
Other Name: Symlin
No Intervention: 2 Usual Regimen
Usual bolus insulin dose at each meal
Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are:
- HbA1c level between 7.5 and 10% inclusive
- Currently using carbohydrate to insulin ratio
- Acceptable form of birth control
- Oral hyperglycemic agents or medications which might affect blood sugar levels
- Recurrent severe hypoglycemia requiring assistance in previous 6 months
- Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility
- Previous use of pramlintide
The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit.
After a baseline visit for all participants, randomization will occur to either Treatment or Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. All participants will have access to staff to assist with insulin dosing. There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study.
Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842075
|United States, Colorado|
|Barbara Davis Center|
|Aurora, Colorado, United States, 80010|
|Principal Investigator:||Peter Chase, MD||University of Colorado, Denver|