Transdermal Basal Insulin Patch Study in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519623
• Other study ID #: IN2007001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 2, 2007
• Last updated: December 3, 2010
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: December 2010
• Source: Altea Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Altea Therapeutics Clinical Research Center	387 Technology Circle, NW, Suite 100, Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Altea Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, 200

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Yes