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A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00607503
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : September 5, 2016
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jaeb Center for Health Research

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Terbutaline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes
Study Start Date : February 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: 1 Drug: Terbutaline

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

Primary Outcome Measures :
  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). [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00607503

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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
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Study Director: Roy W Beck, MD, PhD Jaeb Center for Health Research
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Responsible Party: Jaeb Center for Health Research Identifier: NCT00607503    
Other Study ID Numbers: DirecNet 010
M01RR000069 ( U.S. NIH Grant/Contract )
RR 06022
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action