A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00313183 |
Recruitment Status :
Completed
First Posted : April 12, 2006
Last Update Posted : March 6, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Drug: pramlintide acetate | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
single doses of pramlintide acetate or placebo, given in three different sequences to three cohorts of subjects
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Drug: pramlintide acetate
single subcutaneous doses of 15mcg and 30mcg
Other Name: Symlin |
- 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 effects of Symlin compared to placebo in adolescent subjects with type 1 diabetes on various pharmacodynamic endpoints [ Time Frame: single doses ]

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Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
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 |
Type 1 Diabetes pediatric pramlintide Symlin Amylin |
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 |