DRUG
pramlintide
subcutaneous injection (15 mcg initial dose)prior to meals
Status
Completed
Phase
Not applicable
Enrollment
10
Locations
1
Results
Posted
Publications
1
Study 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).
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 Exclusion factors: * 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.
Interventions
DRUG
subcutaneous injection (15 mcg initial dose)prior to meals
Timeline
First posted
Feb 12, 2009
Study start
Dec 2006
Primary completion
Dec 2009
Study completion
Dec 2009
Results posted
Oct 19, 2012
Registry updated
Jun 23, 2015
Outcomes
HbA1c Value After 28 Days
Time frame · 28
HbA1c values 28 days after randomization
Weight Change After 28 Days Intervention Period
Time frame · 28 days
Mean weight change after 28 days intervention period
Eligibility
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Barbara Davis Center
Aurora, Colorado, United States
Publications
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