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

Stopped early · Not applicable

Conditions studied: Type 1 Diabetes, Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00790699

Run by

Texas Diabetes & Endocrinology, P.A.

People needed

31

Starts

2009-08-01

Expected to finish

2011-11-01

Last updated by the study team

2020-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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. metaclopromide)
• 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

Where it is running

• Texas Diabetes & Endocrinology, PA — Austin, Texas, United States

Full record on ClinicalTrials.gov

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