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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00607503
First received: January 22, 2008
Last updated: January 29, 2012
Last verified: January 2008
  Purpose

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 Intervention Phase
Type 1 Diabetes
Drug: Terbutaline
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: February 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607503

Locations
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
Investigators
Study Director: Roy W Beck, MD, PhD Jaeb Center for Health Research
  More Information

No publications provided

Responsible Party: Roy Beck, MD, PhD, Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00607503     History of Changes
Other Study ID Numbers: DirecNet 010, HD041919-01, HD041915-01, HD041890, HD041918-01, HD041908-01, HD041906-01, M01 RR00069, RR00059, RR 06022, RR00070-41.
Study First Received: January 22, 2008
Last Updated: January 29, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Terbutaline
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 25, 2014