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

This study has been completed.
Sponsor:
Information provided by:
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00313183
First received: April 10, 2006
Last updated: August 14, 2008
Last verified: August 2008
History of Changes

April 10, 2006
August 14, 2008
April 2006
Not Provided
  • 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
Not Provided

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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00313183
137-162
No
Not Provided
Amylin Pharmaceuticals, LLC.
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
August 2008

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