Pramlintide in Adolescents With Type 1 Diabetes
Status
Conditions
Treatments
Details and patient eligibility
About
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).
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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