Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790699
Recruitment Status : Terminated (Lack of patient population)
First Posted : November 13, 2008
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Thomas C. Blevins, M.D., Texas Diabetes & Endocrinology, P.A.

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 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 or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Device: I-PORT Other: standard injections Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : August 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: I-PORT
Treatment group
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
control group
Other: standard injections
The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.




Primary Outcome Measures :
  1. The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]

    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




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790699


Locations
Layout table for location information
United States, Texas
Texas Diabetes & Endocrinology, PA
Austin, Texas, United States, 78731
Sponsors and Collaborators
Texas Diabetes & Endocrinology, P.A.
Amylin Pharmaceuticals, LLC.
Investigators
Layout table for investigator information
Principal Investigator: Thomas C. Blevins, MD Texas Diabetes & Endocrinology
Layout table for additonal information
Responsible Party: Thomas C. Blevins, M.D., Thomas Blevins, MD, Texas Diabetes & Endocrinology, P.A.
ClinicalTrials.gov Identifier: NCT00790699    
Other Study ID Numbers: TDE 001
First Posted: November 13, 2008    Key Record Dates
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020
Last Verified: September 2020
Keywords provided by Thomas C. Blevins, M.D., Texas Diabetes & Endocrinology, P.A.:
diabetes
Symlin
pramlintide acetate
insulin
multiple injection port
I-PORT
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases