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

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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.

Tracking Information
First Submitted Date  ICMJE November 10, 2008
First Posted Date  ICMJE November 13, 2008
Results First Submitted Date  ICMJE May 6, 2014
Results First Posted Date  ICMJE October 20, 2020
Last Update Posted Date October 20, 2020
Study Start Date  ICMJE August 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
The primary outcome will be measured by HbA1c values taken at baseline and the final visit. [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port
Official Title  ICMJE 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)
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.

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 HbA1c values taken at baseline and the final visit

The secondary objective of this study is to measure patient satisfaction, opinions and attitudes toward using the I-PORT™ for insulin and pramlintide administration compared to standard insulin and pramlintide injections. The secondary safety and efficacy evaluations included weight, Glycomark, 7-point SMBG evaluations, CGMS evaluations, incidence of glucose values > 300 mg/dl, incidence of glucose values < 70 mg/dl, and insulin dose before the study period, at month 1, 2 and 3.

The primary patient satisfaction evaluations included Quality of Life Questionnaire and treatment satisfaction questionnaires.

The I-PORT™ is a disposable, low profile injection port through which insulin is injected subcutaneously from a standard syringe or insulin pen.(Figure 1) The I-PORT™ allows multiple insulin injections for up to 72 hours. Once the device is applied, the insertion needle is removed and the cannula remains underneath the skin, serving as a delivery channel into the SQ tissue- one skin puncture every three days. To use the device, the subject places the needle on an injection device, such as a syringe or insulin pen, through the re-sealable septum at the top of the I-PORT™ and injects medication directly into the delivery channel.

Study participants included male and females ages 18 and older who were utilizing a regimen of at least two injections daily of rapid acting insulin and at least two injections daily of pramlintide (Symlin®) with an HbA1c between >6.5 and < 9.0%.

There were 39 patients screened for the study and 8 screen failures leaving 31 subjects ages 18 and older, diagnosed with type 1 or type 2 diabetes mellitus for a minimum of six months. 1 patient dropped out of the study due to an AE and 30 completed the study.

A Randomized, Open-Label, Parallel, Single Center, Comparison Study. Approximately 13 patients with type 1 diabetes and 18 patients with type 2 diabetes were randomized into one of two treatment groups. The randomization was stratified within diabetes type (1 vs. 2) and low (6.5-7.5) vs. high (7.6-9.0) HbA1c level. The randomization process was executed using a computer generated randomization table.

Subject Groups:

  • Group 1- Study subjects administered insulin and pramlintide using standard injection therapy during the entire duration of the trial
  • Group 2- Study subjects administered insulin and pramlintide via a single I-PORT™ for the entire duration of the trial

This study consisted of 8 visits: Screening/Visit 1, Visit 1a (Day -3), Visit 2 (Baseline/Day 0), Visit 3(Day 14), Visit 4(Month 1), Visit 5(Month 2), Visit 5a (Day 81) Visit 6(Month 3).

Subjects participating in this protocol were asked to take their rapid acting insulin preparations and Pramlintide (Symlin®) at the same time using the dose called for by their prescribed regimen established prior to study entry. Subjects used their usual type of insulin preparations obtained by prescription from the commercial pharmacy system. Subjects randomized into Group 2 were given guided instruction on the proper technique of insertion, use and removal of the I-PORT™.

I-PORT™ devices were provided to the subjects and dispensed throughout the trial. Pramlintide (Symlin) was supplied by Amylin Pharmaceuticals.

Patients performed a 7 point SMBG test 3-5 days at baseline and all subjects were instructed on use of a Continuous Glucose Monitoring System (Medtronic iPro). The sensor was inserted for 3-day wear at baseline and blood samples for HbA1c and Glycomark testing were obtained. All subjects completed treatment satisfaction and QoL questionnaires. Each subject was randomized to one of two possible treatment groups.

At each visit, subject diaries were reviewed, weight measurement and a site insertion exam were performed. AEs and concomitant medications were reviewed at each visit.

Patients were asked to do a 7 point SMBG test 3-5 days prior to visit 3,4,5, and 5a. At visit 5a subjects were again instructed on use of a CGMS and a sensor was inserted for 3-day wear.

At the final visit (visit 6), the CGMS was removed and treatment satisfaction and QoL questionnaires were completed by all subjects, and blood samples were taken for HbA1c and Glycomark testing.

Patients were instructed to contact the site if they had 2 glucoses in a row > 300 mg/dl or 2 glucoses in a row of <70 mg/dl. Insulin and/or Pramlintide (Symlin®) were adjusted by PI as needed throughout the trial. Discontinuation of I-PORT™ use was at the discretion of the PI as a rescue measure.

The following QoL questionnaires/ Treatment satisfaction questionnaires were obtained from patients at screening and at the final visit: DSTQ, DSTQ-c, DDS, TSQ,I-PORT™ Device Benefits, Insulin/Symlin Satisfaction Questionnaire, I-PORT™ Device Management, General Diabetes Management, I-PORT™ Device Satisfaction

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes
  • Type 2 Diabetes
Intervention  ICMJE
  • Device: I-PORT
    The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
  • Other: standard injections
    The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
Study Arms  ICMJE
  • Active Comparator: I-PORT
    Treatment group
    Intervention: Device: I-PORT
  • Active Comparator: standard injections
    control group
    Intervention: Other: standard injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 16, 2011)
31
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
50
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790699
Other Study ID Numbers  ICMJE TDE 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas C. Blevins, M.D., Texas Diabetes & Endocrinology, P.A.
Study Sponsor  ICMJE Texas Diabetes & Endocrinology, P.A.
Collaborators  ICMJE Amylin Pharmaceuticals, LLC.
Investigators  ICMJE
Principal Investigator: Thomas C. Blevins, MD Texas Diabetes & Endocrinology
PRS Account Texas Diabetes & Endocrinology, P.A.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP