Back to resultsTransdermal Basal Insulin Patch Study in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PassPort(R) Transdermal Insulin Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring diabetes, insulin, blood sugar, type 1 diabetes, insulin dependent diabetes, transdermal
Eligibility 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
Sites / Locations
- Altea Therapeutics Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PassPort(R) Transdermal Insulin Delivery System
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519623
Brief Title
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
Official Title
Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Altea Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
diabetes, insulin, blood sugar, type 1 diabetes, insulin dependent diabetes, transdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PassPort(R) Transdermal Insulin Delivery System
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
PassPort(R) Transdermal Insulin Delivery System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
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
Title
Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)
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
Secondary Outcome Measure Information:
Title
Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicky Spratlin, M.D.
Organizational Affiliation
Altea Therapeutics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altea Therapeutics Clinical Research Center
City
387 Technology Circle, NW, Suite 100, Atlanta
State/Province
Georgia
ZIP/Postal Code
30313
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Links:
URL
http://www.alteatherapeutics.com
Description
Altea website
Learn more about this trial
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
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