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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborator: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00607503 |
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 I |
| 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 |
| 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
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | Roy W Beck, MD, PhD | Jaeb Center for Health Research |
More Information
| 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 |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Terbutaline Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Sympathomimetics Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |