The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.
| Group | Value (% of HbA1c) | Spread |
|---|---|---|
| I-PORT | 7.68 | .65 |
| Standard Injections | 7.93 | .73 |
Trial · Interventional
TerminatedNot applicableResults postedRegistry dataThis trial was stopped early.
Reason given at the registry: Lack of patient population
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 stopped early · 1 with posted results
Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port
NCT00790699Aug 2009 to Nov 2011
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.
Active comparator
I-PORT
Treatment group
Active comparator
standard injections
control group
Outcomes the sponsor listed as primary.
The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.
Time frame · 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).
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
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (% of HbA1c) | Spread |
|---|---|---|
| I-PORT | 7.68 | .65 |
| Standard Injections | 7.93 | .73 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Visit 1 | 66.07 | 13.34 |
| Visit 6 | 65.66 | 13.94 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| IportTreatment group/ Iport Users | – | 0 / 16 | 11 / 16 |
| Standard InjectionsControl group/ Standard Injections | – | 0 / 14 | 7 / 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
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