A pilot trial of pramlintide home usage in adolescents with type 1 diabetes

Abstract

Objective: The objective of this study was to evaluate the safety and efficacy of home pramlintide use in adolescents with type 1 diabetes.

Patients and methods: This was a randomized, 28-day pilot trial of pramlintide (maximum dose: 30 microg per meal) in 10 adolescents aged 13 to 17 years. End points included changes in hemoglobin A1c (HbA1c) values, body weight, and postprandial peak blood glucose levels and area under the curve on continuous glucose monitoring.

Results: Changes in HbA1c values, body weight, and total insulin dose declined in the treatment group compared with the control group (bootstrapped, P <or= .02 for each). The treatment group also demonstrated lower average dinner area under the curve (P = .02) and lower maximum breakfast (P = .03) and dinner (P = .02) postprandial blood glucose values.

Conclusions: Pramlintide can help some adolescents to decrease postprandial hyperglycemia, HbA1c values, body weight, and insulin dosages. Additional large-scale trials should now be considered.

Trial registration: ClinicalTrials.gov NCT00842075.