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

NCT00607503 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-09-05

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Roy W Beck, MD, PhD · Jaeb Center for Health Research

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00607503 on ClinicalTrials.gov