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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: pramlintide acetate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
 Drug: pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg
Other Name: Symlin


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the pharmacokinetics of Symlin in adolescent subjects with type 1 diabetes [ Time Frame: single doses ]
  2. To assess the safety and tolerability of Symlin in adolescent subjects with type 1 diabetes [ Time Frame: single doses ]

Secondary Outcome Measures :
  1. To evaluate the effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints [ Time Frame: single doses ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313183


Locations
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United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Missouri
Research Site
Kansas City, Missouri, United States
United States, New York
Research Site
New York, New York, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00313183    
Other Study ID Numbers: 137-162
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: January 2015
Keywords provided by AstraZeneca:
Type 1 Diabetes
pediatric
pramlintide
Symlin
Amylin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Pramlintide
Hypoglycemic Agents
Physiological Effects of Drugs