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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 diabetes

To 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

Page last updated: August 23, 2015

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