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



Status:Terminated
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:August 2009
End Date:November 2011

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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)

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.


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
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