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Transdermal Basal Insulin Patch Study in Type 1 Diabetes

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects for the IN2007001 study were recruited between August 2007 and November 2007 by the Phase 1 Clinical Research Unit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Transdermal Patch PassPort(r) Transdermal Insulin Delivery System

Participant Flow:   Overall Study
    Transdermal Patch
STARTED   9 
COMPLETED   8 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Transdermal Patch PassPort(r) Transdermal Insulin Delivery System

Baseline Measures
   Transdermal Patch 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.4  (10.8) 
Gender 
[Units: Participants]
 
Female   4 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures

1.  Primary:   Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)   [ 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 ]

2.  Primary:   Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)   [ Time Frame: Glucose infusion rates were adjusted every 10 minutes as necessary ]

3.  Secondary:   Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients   [ Time Frame: Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal ]
Results not yet reported.   Anticipated Reporting Date:   11/2010  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pei-Ling Roerig, Sr. Manager Clinical Research, Altea Therapeutics
Organization: Altea Therapeutics
phone: 404-835-6415
e-mail: proerig@alteatherapeutics.com


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