A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00313183
First received: April 10, 2006
Last updated: June 4, 2014
Last verified: June 2014
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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
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 |
| 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 |
| 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
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00313183 History of Changes |
| Other Study ID Numbers: | 137-162 |
| Study First Received: | April 10, 2006 |
| Last Updated: | June 4, 2014 |
| 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 Autoimmune Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases |
Metabolic Diseases Pramlintide Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on March 01, 2015