Pramlintide in Adolescents With Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | December 2006 |
| End Date: | December 2009 |
| Contact: | Patricia L Burdick, BS |
| Email: | patricia.burdick@ucdenver.edu |
| Phone: | 303-724-6772 |
Effects of 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).
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.
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
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