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Sponsors and Collaborators: |
Texas Diabetes & Endocrinology, P.A. Amylin Pharmaceuticals, Inc. |
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Information provided by: | Texas Diabetes & Endocrinology, P.A. |
ClinicalTrials.gov Identifier: | NCT00790699 |
The purpose of this study is to determine whether injecting Symlin and insulin through a multiple injection port is safe and effective. This will be measured by HbA1c values taken at the beginning of the study and at the final visit. The secondary objective of the study is to measure patient satisfaction toward using the multiple injection port.
Condition | Intervention |
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Type 1 Diabetes Type 2 Diabetes |
Device: I-PORT Other: standard injections |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Parallel, Single Center, Comparison, Pilot Study Evaluating the Safety and Efficacy of Using Symlin Alongside Insulin in a Multiple Injection Port (I-PORT) |
Estimated Enrollment: | 50 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I-PORT: Active Comparator |
Device: I-PORT
The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
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standard injections: Active Comparator |
Other: standard injections
The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Karah C. Dalton, BS | 512.334.3505 | kdalton@texasdiabetes.com |
Contact: Alison Verlenden, BS | 512.334.3505 | averlenden@texasdiabetes.com |
United States, Texas | |
Texas Diabetes & Endocrinology, PA | |
Austin, Texas, United States, 78731 |
Principal Investigator: | Thomas C. Blevins, MD | Texas Diabetes & Endocrinology |
Responsible Party: | Texas Diabetes & Endocrinology, PA ( Thomas C. Blevins, MD, Sponsor/Investigator ) |
Study ID Numbers: | TDE 001 |
Study First Received: | November 10, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00790699 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diabetes Symlin pramlintide acetate |
insulin multiple injection port I-PORT |
Metabolic Diseases Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 Insulin Hypoglycemic Agents |
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Pramlintide Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Autoimmune Diseases Immune System Diseases Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Insulin |
Pharmacologic Actions Hypoglycemic Agents Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Pramlintide Glucose Metabolism Disorders |