A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus - Full Text View

Purpose

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	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: pramlintide acetate	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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


Enrollment:	12
Study Start Date:	April 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	12 Years to 17 Years (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313183

Locations


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


Study Director:	Lisa Porter, MD	Amylin Pharmaceuticals, LLC.

More Information


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00313183 History of Changes
Other Study ID Numbers:	137-162
Study First Received:	April 10, 2006
Last Updated:	March 5, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


Type 1 Diabetes pediatric pramlintide Symlin Amylin

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Pramlintide	Islet Amyloid Polypeptide Hypoglycemic Agents Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Amylin Receptor Agonists Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016