A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes Mellitus
Intervention: pramlintide acetate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, LLC.
Summary
This study will be the first evaluation of Symlin in adolescent subjects with type 1
diabetes mellitus and is designed to evaluate the blood levels (pharmacokinetics),
biochemical and physiological effects (pharmacodynamics), and safety and tolerability of
Symlin in these subjects.
Clinical Details
Official title: A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of SYMLIN in Adolescent Subjects With Type 1 Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetesTo assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes
Secondary outcome: To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosed with type 1 diabetes mellitus for at least 1 year prior to screening
- Be on a stable regimen requiring multiple daily injections of basal and mealtime
insulin or continuous subcutaneous insulin infusion for at least 2 weeks prior to
screening
- HbA1c between 6. 0% and 10. 0%, inclusive, at screening
- Body weight >=50 kg at screening
Exclusion Criteria:
- Currently being treated with the following medications: *Any oral antihyperglycemic
agent; *Drugs that directly affect gastrointestinal motility
- Has been previously treated with Symlin/pramlintide (or has participated in a
Symlin/pramlintide clinical study)
- Has received any investigational drug within 1 month of screening
Locations and Contacts
Research Site, Aurora, Colorado, United States
Research Site, Kansas City, Missouri, United States
Research Site, New York, New York, United States
Additional Information
Starting date: April 2006
Last updated: March 5, 2015
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