Type 2 Diabetes Clinical Trial
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)
NCT number | NCT00790699 |
Other study ID # | TDE 001 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2009 |
Est. completion date | November 2011 |
Verified date | September 2020 |
Source | Texas Diabetes & Endocrinology, P.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 31 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Diabetes & Endocrinology, PA | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Diabetes & Endocrinology, P.A. | Amylin Pharmaceuticals, LLC. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months. | 3 months | ||
Secondary | 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). | Scores from the QOL and treatment satisfaction measures collected at Visit 1 and Visit 6. To determine if patient satisfaction and patient opinions and attitudes toward using the I-PORT™ for insulin and Symlin® administration compared to standard insulin and Symlin® injections was significantly different for patients in the treatment and control groups, repeated-measures analysis of variance (RM-ANOVA) was conducted on scores from the quality of life and treatment satisfaction measures collected at Visit 1 and Visit 6. The RM-ANOVA results were evaluated to determine if any statistically significant changes occurred. TSQ- lower numbers show less satisfied. DDS- Lower numbers show decrease in distress. DTSQ- Lower numbers show less satisfied. One patient did not complete Visit 6 questionnaires. Scale ranges: DDS scale range: 17- 102 DTSQc scale range: 16- 96 Insulin /Symlin Treatment Satisfaction Questionnaire scale range: 15-90 |
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