A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes
11 other identifiers
interventional
9
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2008
Shorter than P25 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedSeptember 5, 2016
September 1, 2016
7 months
January 22, 2008
September 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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).
1 month
Study Arms (1)
1
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Age 12.0 years to less than 18.0 years
- HbA1c \<8.0%
- Use of basal: bolus insulin therapy with either an insulin pump or glargine with MDI of a short-acting insulin for at least 6 months (approximately 5 pump and 5 MDI users will be enrolled)
- Availability of home computer to download the CGM
- For females: not currently pregnant, negative pregnancy test, and not intending to become pregnant during the next 3 months
- Parent/guardian and subject understand the study protocol and agree to comply with it
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject if required by IRB
You may not qualify if:
- Severe hypoglycemic event (seizure or coma) or diabetic ketoacidosis in the past 6 months
- Cardiac disease, including prolonged QT interval on EKG or pathologic arrhythmia
- An EKG will be done either prior to the CRC admission or during the CRC admission prior to the first dose of terbutaline
- Treatment for hypertension or blood pressure exceeding the 90th percentile for age and height
- Current treatment for a seizure disorder
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months or with a beta adrenergic agonist more than once a month
- Cystic fibrosis
- Use of MAO inhibitors, tricyclic antidepressants, or beta blockers
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
- Medical condition that in the judgment of the investigator might interfere with the completion of the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, 94305, United States
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Jaeb Center for Health Research
Tampa, Florida, 33647, United States
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242, United States
Washington University
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Roy W Beck, MD, PhD
Jaeb Center for Health Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2008
First Posted
February 5, 2008
Study Start
February 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
September 5, 2016
Record last verified: 2016-09