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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 1 Diabetes
Type 2 Diabetes
Interventions Device: I-PORT
Other: standard injections
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title I-PORT Standard Injections
Hide Arm/Group Description I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections. standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections. The standard injections are usually 3-4 times daily.
Period Title: Overall Study
Started 17 14
Completed 16 14
Not Completed 1 0
Arm/Group Title I-PORT Standard Injections Total
Hide Arm/Group Description I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections. standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections. Total of all reporting groups
Overall Number of Baseline Participants 17 14 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  82.4%
13
  92.9%
27
  87.1%
>=65 years
3
  17.6%
1
   7.1%
4
  12.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 31 participants
45  (16.38) 54  (10.60) 49.5  (13.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Female
12
  70.6%
13
  92.9%
25
  80.6%
Male
5
  29.4%
1
   7.1%
6
  19.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Hispanic or Latino
2
  11.8%
4
  28.6%
6
  19.4%
Not Hispanic or Latino
15
  88.2%
10
  71.4%
25
  80.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.9%
1
   7.1%
2
   6.5%
White
16
  94.1%
13
  92.9%
29
  93.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 14 participants 31 participants
17 14 31
Glycomark  
Mean (Standard Deviation)
Unit of measure:  ug/mL
Number Analyzed 17 participants 14 participants 31 participants
6.49  (3.69) 5.05  (3.71) 5.84  (3.71)
Type of Diabetes Breakdown  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Type 1 Diabetics
7
  41.2%
6
  42.9%
13
  41.9%
Type 2 Diabetes
10
  58.8%
8
  57.1%
18
  58.1%
Type 1 diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
7
  41.2%
6
  42.9%
13
  41.9%
1.Primary Outcome
Title The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.
Hide Description [Not Specified]
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title I-PORT Standard Injections
Hide Arm/Group Description:
I-PORT: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
standard injections: The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.
Overall Number of Participants Analyzed 17 14
Mean (Standard Deviation)
Unit of Measure: % of HbA1c
Screening 7.68  (.65) 7.93  (.73)
Month 3 7.34  (.60) 7.42  (.90)
Baseline 7.66  (.35) 7.70  (.67)
2.Secondary Outcome
Title 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).
Hide 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

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Results broken down further to reflect results in each group: Iport vs. Standard Injection subjects and total number of subjects who completed the patient reports at visit 1 and Visit 6.
Arm/Group Title Visit 1 Visit 6
Hide Arm/Group Description:
Patient reports at visit 1
Patient reports at last visit (3 months)
Overall Number of Participants Analyzed 31 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Satisfaction Control Number Analyzed 14 participants 14 participants
66.07  (13.34) 65.66  (13.94)
Treatment Satisfaction Treatment Number Analyzed 17 participants 16 participants
67.16  (12.30) 54.28  (16.71)
DTSQ Control Number Analyzed 14 participants 14 participants
37.46  (5.95) 34.54  (7.40)
DTSQ Treatment Number Analyzed 17 participants 16 participants
35.41  (6.78) 33.25  (6.15)
Diabetes Distress Scale Control Number Analyzed 14 participants 14 participants
38.20  (10.56) 33.86  (8.19)
Diabetes Distress Scale Treatment Number Analyzed 17 participants 16 participants
34.00  (10.57) 31.45  (10.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Visit 1, Visit 6
Comments The results were evaluated to determine if any statistically significant changes in any of these measures between the first and final visit occurred and if these changes were associated with membership in the treatment or control group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments [Not Specified]
Method RM-ANOVA
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iport Standard Injections
Hide Arm/Group Description Treatment group/ Iport Users Control group/ Standard Injections
All-Cause Mortality
Iport Standard Injections
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Iport Standard Injections
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.7%
Iport Standard Injections
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/16 (68.75%)      7/14 (50.00%)    
Endocrine disorders     
Hyperglycmia   1/16 (6.25%)  1 0/14 (0.00%)  0
Eye disorders     
Iritis   1/16 (6.25%)  1 0/14 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain   1/16 (6.25%)  1 0/14 (0.00%)  0
Bloating   1/16 (6.25%)  1 0/14 (0.00%)  0
Gastroenteritis   1/16 (6.25%)  1 0/14 (0.00%)  0
Diarrhea   1/16 (6.25%)  1 0/14 (0.00%)  0
Black liquid stool   1/16 (6.25%)  1 0/14 (0.00%)  0
Nausea   0/16 (0.00%)  0 1/14 (7.14%)  1
General disorders     
Mettalic taste   1/16 (6.25%)  1 0/14 (0.00%)  0
mettalic smell   1/16 (6.25%)  1 0/14 (0.00%)  0
confusion   1/16 (6.25%)  1 0/14 (0.00%)  0
Boil   0/16 (0.00%)  0 1/14 (7.14%)  1
swollen lymph node   0/16 (0.00%)  0 1/14 (7.14%)  1
dizziness   0/16 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations     
Upper respiratory infections   3/16 (18.75%)  3 3/14 (21.43%)  3
Urinary tract infections   2/16 (12.50%)  2 0/14 (0.00%)  0
Common Cold   1/16 (6.25%)  1 2/14 (14.29%)  2
Sinus infection   1/16 (6.25%)  1 0/14 (0.00%)  0
Yeast infection   1/16 (6.25%)  1 1/14 (7.14%)  1
Parvo Virus   1/16 (6.25%)  1 0/14 (0.00%)  0
tooth abcess   0/16 (0.00%)  0 1/14 (7.14%)  1
bacterial bronchitis   0/16 (0.00%)  0 1/14 (7.14%)  1
pneumonia   0/16 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
left wrist fracture   1/16 (6.25%)  1 0/14 (0.00%)  0
Low back pain   1/16 (6.25%)  1 0/14 (0.00%)  0
Dental implants   1/16 (6.25%)  1 0/14 (0.00%)  0
Trigger finger release   1/16 (6.25%)  1 0/14 (0.00%)  0
Reproductive system and breast disorders     
uterine ablation   1/16 (6.25%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Blevins,MD
Organization: Texas Diabetes & Endocrinology
Phone: 5812.334.3505
EMail: blevins@texasdiabetes.com
Layout table for additonal information
Responsible Party: Thomas C. Blevins, M.D., Texas Diabetes & Endocrinology, P.A.
ClinicalTrials.gov Identifier: NCT00790699    
Other Study ID Numbers: TDE 001
First Submitted: November 10, 2008
First Posted: November 13, 2008
Results First Submitted: May 6, 2014
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020