A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes
The purpose of the study is to gain experience with the use of terbutaline in children with T1D and to determine that there is not a frequent serious, unexpected, uncontrollable effect on short-term glycemic control. Some information also will be obtained with regard to whether terbutaline, in the dosing being used in the study, is sufficiently well tolerated to expect that adherence will be satisfactory in a large randomized trial. In addition, this pilot study will provide data on the accuracy of a continuous glucose monitor during terbutaline use to verify that the drug does not impact on sensor function.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes|
- Safety of bedtime administration of the epinephrine simulating β2 adrenergic agonist terbutaline to reduce the incidence of nocturnal hypoglycemia without compromising glycemic control in youth with type 1 diabetes (T1D). [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Each subject will be treated with terbutaline for 21-28 days following the initiation of treatment during the CRC admission.
Subjects weighing between 25 and 45 kg will be treated with a nightly oral dose of 2.5 mg and subjects who weigh more than 45 kg will be treated with 3.75 mg.
The standard 2.5 mg terbutaline tablets available in a pharmacy will be used in the study, with subjects taking either 1 or 1.5 tablets nightly.
Other Name: Brethine
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|United States, California|
|Division of Pediatric Endocrinology and Diabetes, Stanford University|
|Stanford, California, United States, 94305|
|United States, Connecticut|
|Department of Pediatrics, Yale University School of Medicine|
|New Haven, Connecticut, United States, 06519|
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|Jaeb Center for Health Research|
|Tampa, Florida, United States, 33647|
|United States, Iowa|
|Department of Pediatrics, University of Iowa Carver College of Medicine|
|Iowa City, Iowa, United States, 52242|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Study Director:||Roy W Beck, MD, PhD||Jaeb Center for Health Research|