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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00313183
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE April 10, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE April 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
  • 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
Change History Complete list of historical versions of study NCT00313183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2007)
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints [ Time Frame: single doses ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE Drug: pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg
Other Name: Symlin
Study Arms  ICMJE Experimental: 1
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
Intervention: Drug: pramlintide acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2006)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313183
Other Study ID Numbers  ICMJE 137-162
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
PRS Account AstraZeneca
Verification Date January 2015

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