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Trial record 46 of 2403 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

Transdermal Basal Insulin Patch Study in Type 1 Diabetes

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: NCT00519623
Recruitment Status : Completed
First Posted : August 22, 2007
Results First Posted : December 30, 2010
Last Update Posted : December 30, 2010
Sponsor:
Information provided by:
Altea Therapeutics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Other: PassPort(R) Transdermal Insulin Delivery System
Enrollment 9
Recruitment Details Subjects for the IN2007001 study were recruited between August 2007 and November 2007 by the Phase 1 Clinical Research Unit.
Pre-assignment Details Subjects stopped intermediate/long-acting insulin 48 hours prior to treatment or discontinued use of their insulin pump when they arrived for the treatment. There was a run-in period in which IV insulin lispro was administered to achieve a glucose clamp target of 100 mg/dL prior to application of the patch.
Arm/Group Title Transdermal Patch
Hide Arm/Group Description PassPort(r) Transdermal Insulin Delivery System
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Transdermal Patch
Hide Arm/Group Description PassPort(r) Transdermal Insulin Delivery System
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
35.4  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
Hide Description Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.
Time Frame Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects completed
Arm/Group Title Transdermal Patch
Hide Arm/Group Description:
PassPort(r) Transdermal Insulin Delivery System
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: uU/mL
33.0  (6.3)
2.Primary Outcome
Title Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)
Hide Description Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.
Time Frame Glucose infusion rates were adjusted every 10 minutes as necessary
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Patch
Hide Arm/Group Description:
PassPort(r) Transdermal Insulin Delivery System
Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: mg/kg/min
4.9  (1.0)
3.Secondary Outcome
Title Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
Hide Description Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site.
Time Frame Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal
Outcome Measure Data Not Reported
Time Frame Adverse events were collected from the time of study treatment until the last follow up visit (7 days after patch removal).
Adverse Event Reporting Description Systematic assessments of adverse events were performed throughout the study via clinical staff assessments/questions and laboratory testing. In addition, adverse events were self-reported by subjects throughout the study.
 
Arm/Group Title Transdermal Patch
Hide Arm/Group Description PassPort(r) Transdermal Insulin Delivery System
All-Cause Mortality
Transdermal Patch
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal Patch
Affected / at Risk (%) # Events
Total   0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Transdermal Patch
Affected / at Risk (%) # Events
Total   4/9 (44.44%)    
Gastrointestinal disorders   
Nausea  1  1/9 (11.11%)  1
Injury, poisoning and procedural complications   
IV Site Pain/Swelling  1  1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders   
Shoulder Pain  1  1/9 (11.11%)  1
Nervous system disorders   
Headache  1  2/9 (22.22%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
This was a small exploratory study to evaluate the PK, PD and tolerability of a selected Basal Insulin PassPort(r) System configuration in C-peptide negative type 1 diabetes subjects.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.

PI is restricted from using, disclosing, presenting or publishing trial information without the prior written consent from the Sponsor.

PI is not an employee of the Sponsor but was paid to conduct the study at the Sponsor's Phase 1 Clinical Resarch Unit.

Results Point of Contact
Name/Title: Pei-Ling Roerig, Sr. Manager Clinical Research, Altea Therapeutics
Organization: Altea Therapeutics
Phone: 404-835-6415
Publications of Results:
Smith, A, Zerkel, K, Roerig, P, Mills, S, Humphries, C, Durland, R, Spratlin, V, "Transdermal Delivery of Insulin in Patients with Type 1 Diabetes," American Diabetes Association 68th Scientific Sessions, Abstract 309-OR, Diabetes 57 Supplement 1:A88, 2008.
Responsible Party: Alan Smith, Vice President, Product Development, Clinical R&D, and Project Management, Altea Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT00519623     History of Changes
Other Study ID Numbers: IN2007001
First Submitted: August 2, 2007
First Posted: August 22, 2007
Results First Submitted: December 3, 2010
Results First Posted: December 30, 2010
Last Update Posted: December 30, 2010