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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00313183
First received: April 10, 2006
Last updated: March 5, 2015
Last verified: January 2015

April 10, 2006
March 5, 2015
April 2006
August 2007   (final data collection date for primary outcome measure)
  • To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes [ Time Frame: single doses ]
  • To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes [ Time Frame: single doses ]
  • 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
Complete list of historical versions of study NCT00313183 on ClinicalTrials.gov Archive Site
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints [ Time Frame: single doses ]
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
Not Provided
Not Provided
 
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Drug: pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg
Other Name: Symlin
Experimental: 1
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
Intervention: Drug: pramlintide acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00313183
137-162
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
AstraZeneca
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP