Status:
TERMINATED
Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port
Lead Sponsor:
Texas Diabetes & Endocrinology, P.A.
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Type 1 Diabetes
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The primary objective of this clinical study is to demonstrate the safety and efficacy of giving pramlintide and insulin in the same multi-port injection device (I-PORT™). Efficacy was measured by HbA...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00790699
Start Date
August 1 2009
End Date
November 1 2011
Last Update
October 20 2020
Active Locations (1)
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1
Texas Diabetes & Endocrinology, PA
Austin, Texas, United States, 78731