Transdermal Basal Insulin Patch Study in Type 1 Diabetes

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

Detailed Description
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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

Official Title
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Pharmacokinetic/Pharmacodynamic Study of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: PassPort(R) Transdermal Insulin Delivery System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PassPort(R) Transdermal Insulin Delivery System<br> | Other: PassPort(R) Transdermal Insulin Delivery System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 
| 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. | Glucose infusion rates were adjusted every 10 minutes as necessary | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, insulin, blood sugar, type 1 diabetes, insulin dependent diabetes, transdermal