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Transdermal Basal Insulin Patch Study in Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519623
First Posted: August 22, 2007
Last Update Posted: December 30, 2010
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.
Information provided by:
Altea Therapeutics
August 2, 2007
August 22, 2007
December 3, 2010
December 30, 2010
December 30, 2010
August 2007
November 2007   (Final data collection date for primary outcome measure)
  • 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 ]
    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.
  • 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 ]
    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.
PK levels of insulin [ Time Frame: 12 or 24 hours ]
Complete list of historical versions of study NCT00519623 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
Not Provided
 
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.

The study is looking for patients that meet the following criteria:

  • Duration of type diabetes greater than or equal to 10 years
  • HbA1C less than or equal to 9.0%
  • C-peptide negative
  • Ages 18 - 65, male or female
  • Body Mass Index (BMI) 18.5 - 32
  • Non-smoker
  • No advanced diabetes complications
  • Not pregnant or breast feeding
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes
Other: PassPort(R) Transdermal Insulin Delivery System
The PassPort(R) Transdermal Insulin Delivery System is a drug-device combination product used to create micropores in the skin to enable transdermal delivery of insulin.
Experimental: PassPort(R) Transdermal Insulin Delivery System
Intervention: Other: PassPort(R) Transdermal Insulin Delivery System
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
December 2007
November 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Duration of type 1 diabetes greater than or equal to 10 years
  • HbA1c less than or equal to 9.0%
  • C-peptide negative
  • Ages 18 - 65, male or female
  • BMI 18.5 - 32
  • Non- smoker
  • No advance diabetes complications
  • Not pregnant or breast feeding

Exclusion Criteria:

  • Arm or leg rashes, open wounds, or skin conditions
  • Psychiatric disorders
  • Participation in a clinical research trial in last 3 months
  • Clinically significant acute illness
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00519623
IN2007001
No
Not Provided
Not Provided
Alan Smith, Vice President, Product Development, Clinical R&D, and Project Management, Altea Therapeutics Corporation
Altea Therapeutics
Not Provided
Principal Investigator: Vicky Spratlin, M.D. Altea Therapeutics
Altea Therapeutics
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP