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
Sponsor study identifier
interventional
12
1 country
1
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
January 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
July 16, 2007
Actual (reported)July 17, 2007
Actual (reported)January 2008
Actual (reported)January 2008
Actual (reported)Fasting and postprandial pramlintide pharmacokinetics
Four months
Hemoglobin A1c, body weight, blood glucose variability, patient satisfaction
four months
Hemoglobin A1c
16 weeks
Interventional, continuous pramlintide infusion at 9 micrograms/hr plus 60 microgram meal bolus plus continuous insulin basal-bolus subcutaneous infusion
pramlintide injection, 9 mcg/hr plus 60 mcg premeal boluses
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Diabetes & Endocrine Consultants
Chattanooga, Tennessee, 37403, United States
Huffman DM, McLean GW, Seagrove MA. Continuous subcutaneous pramlintide infusion therapy in patients with type 1 diabetes: observations from a pilot study. Endocr Pract. 2009 Nov-Dec;15(7):689-95. doi: 10.4158/EP09044.ORR1.
David M Huffman, MD
University Diabetes & Endocrine Consultants
12 participants (actual enrollment reported by the registry).
First Submitted
July 16, 2007
First Posted
July 17, 2007
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
Contact the study team to confirm eligibility.
Primary Completion
January 2008
Actual (reported)Study Completion
January 2008
Actual (reported)Last Updated
January 16, 2013
Record last verified: 2013-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: