A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313183
• Other study ID #: 137-162
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2006
• Last updated: March 5, 2015
• Start date: April 2006
• Est. completion date: August 2007

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg

Locations

Country	Name	City	State
United States	Research Site	Aurora	Colorado
United States	Research Site	Kansas City	Missouri
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes		single doses
Primary	To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes		single doses
Secondary	To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints		single doses