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
Diabetes Mellitus, Type 1
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