Transdermal Basal Insulin Patch Study in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Altea Therapeutics
ClinicalTrials.gov Identifier:
NCT00519623
First received: August 2, 2007
Last updated: December 3, 2010
Last verified: December 2010
  Purpose

This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.


Condition Intervention Phase
Type 1 Diabetes
Other: PassPort(R) Transdermal Insulin Delivery System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Altea Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 9
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PassPort(R) Transdermal Insulin Delivery System 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.

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519623

Locations
United States, Georgia
Altea Therapeutics Clinical Research Center
387 Technology Circle, NW, Suite 100, Atlanta, Georgia, United States, 30313
Sponsors and Collaborators
Altea Therapeutics
Investigators
Principal Investigator: Vicky Spratlin, M.D. Altea Therapeutics
  More Information

Publications:
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
Study First Received: August 2, 2007
Results First Received: December 3, 2010
Last Updated: December 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Altea Therapeutics:
diabetes
insulin
blood sugar
type 1 diabetes
insulin dependent diabetes
transdermal

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014