IDDM Clinical Trial
Official title:
A Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Pramlintide Acetate When Administered by Subcutaneous Infusion in a Basal-Bolus Manner as an Adjunct to Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes
This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.
DESCRIPTION OF STUDY:
To participate in the study, you must have Type I diabetes mellitus and be taking insulin
using an insulin pump, and have a hemoglobin A1c level between 7.0% and 10.0%. You will not
be permitted to participate in the study if you have taken pramlintide (Symlin) during the
previous three months. The study will consist of seven visits to the Study Center over a
four-month period. Subjects will undergo meal tolerance testing at beginning and end of
study period. Continuous blood glucose monitoring will be performed on three occasions
during the study.
Pramlintide will be begun at a single basal rate of 1.5 units/hr. Bolus therapy will be
begun thereafter per standard manufacturer protocol. Subjects will be monitored for three
months on basal-bolus pramlintide therapy.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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