A Pilot Study of Continuous Subcutaneous Pramlintide 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Fasting and postprandial pramlintide pharmacokinetics [ Time Frame: Four months ] [ Designated as safety issue: No ]
- Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction [ Time Frame: four months ] [ Designated as safety issue: Yes ]
- Hemoglobin A1c [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Interventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion
Drug: Continuous Pramlintide infusion
pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
Other Name: pramlintide
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.
|United States, Tennessee|
|University Diabetes & Endocrine Consultants|
|Chattanooga, Tennessee, United States, 37403|
|Principal Investigator:||David M Huffman, MD||University Diabetes & Endocrine Consultants|