Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port

This study has been terminated.
(Lack of patient population)
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Thomas C. Blevins, M.D., Texas Diabetes & Endocrinology, P.A.
ClinicalTrials.gov Identifier:
NCT00790699
First received: November 10, 2008
Last updated: November 16, 2011
Last verified: December 2009
  Purpose

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
Type 1 Diabetes
Type 2 Diabetes
Device: I-PORT
Other: standard injections

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Texas Diabetes & Endocrinology, P.A.:

Primary Outcome Measures:
  • The primary outcome will be measured by HbA1c values taken at baseline and the final visit. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary outcome will measure patient satisfaction, opinions and attitudes toward using the multiple injection port for insulin and Symlin administration compared to standard Symlin injections (measured through using questionnaires). [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I-PORT Device: I-PORT
The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
Active Comparator: standard injections Other: standard injections
The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female ages 18 and up
  • utilizing a regimen of at least two injections daily of insulin and at least two injections daily of Symlin
  • able to understand and sign an informed consent form and HIPPA form
  • agrees to all study visits and procedures
  • HbA1c between >6.5 and <9.0 (inclusive)

Exclusion Criteria:

  • history or current diagnosis of chronic disease which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study
  • history of malignancy with in the last five years of study entry (other than basal cell carcinoma)
  • current use of any drugs that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine), agents that slow intestinal absorption of nutrients (e.g. a-glucosidase inhibitors) or promotility agents (e.g. metachlopromide)
  • any contraindication of Symlin or I-PORT according to the package labeling
  • are female and pregnant, lactating or planning to become pregnant during the duration of the trial
  • are poorly compliant with their current insulin and/or Symlin regimen, as defined by their HCP
  • has history of known hypersensitivity to plastics or polymers
  • treatment with any investigational drug within one month prior to enrollment
  • myocardial infarction or stroke within six months prior to screening
  • initiated use of Symlin pen or any Insulin pen in lieu of a vial in last 4 weeks (pen use is okay as long as they have been using it for at least 4 weeks prior to screening visit)
  • female subjects of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, double barrier methods, Intrauterine devices, surgical sterilization or vasectomized partner)
  • have confirmed diagnosis of gastroparesis
  • have hypoglycemia unawareness
  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: NCT00790699

Locations
United States, Texas
Texas Diabetes & Endocrinology, PA
Austin, Texas, United States, 78731
Sponsors and Collaborators
Texas Diabetes & Endocrinology, P.A.
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Thomas C. Blevins, MD Texas Diabetes & Endocrinology
  More Information

No publications provided

Responsible Party: Thomas C. Blevins, M.D., Thomas Blevins, MD, Texas Diabetes & Endocrinology, P.A.
ClinicalTrials.gov Identifier: NCT00790699     History of Changes
Other Study ID Numbers: TDE 001
Study First Received: November 10, 2008
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Diabetes & Endocrinology, P.A.:
diabetes
Symlin
pramlintide acetate
insulin
multiple injection port
I-PORT

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014