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Trial · Interventional

TerminatedNot applicableResults postedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Measures Pramlintide (Symlin), does not give it. It appears in an outcome measure.

Overview

Status
Terminated
Phase
Not applicable
Enrollment
31 participants (actual)
Sponsor
Texas Diabetes & Endocrinology, P.A. · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2009
Primary completion
Nov 2011
Completion
Nov 2011
First posted
13 Nov 2008 (estimated)
Last update posted
20 Oct 2020
Conditions
Type 1 Diabetes · Type 2 Diabetes

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. N/A

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

    NCT00790699

    Aug 2009 to Nov 2011

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • I-PORTDevice
  • standard injectionsOther

Arms2

  • Active comparator

    I-PORT

    Treatment group

  • Active comparator

    standard injections

    control group

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.

    Time frame · 3 months

Secondary outcomes(1)
  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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.

GroupValue (% of HbA1c)Spread
I-PORT7.68.65
Standard Injections7.93.73
Secondary and other outcome results(1)
Secondary outcomeMean· 3 months

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).

GroupValue (units on a scale)Spread
Visit 166.0713.34
Visit 665.6613.94

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IportTreatment group/ Iport Users–0 / 1611 / 16
Standard InjectionsControl group/ Standard Injections–0 / 147 / 14

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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