Transdermal Basal Insulin Patch Study in Type 1 Diabetes

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: PassPort(R) Transdermal Insulin Delivery System

• Registration Number: NCT00519623
• Lead Sponsor: Altea Therapeutics

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

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-20
• Study First Posted: 2007-08-22
• Primary Completion: 2007-11
• Study Completion: 2007-12
• Status Verified: 2010-12
• Results First Submitted: 2010-12-03
• Results First Submitted QC: 2010-12-03
• Last Update Submitted: 2010-12-03
• Results First Posted: 2010-12-30
• Last Update Posted: 2010-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PassPort(R) Transdermal Insulin Delivery System	PassPort(R) Transdermal Insulin Delivery System	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)	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	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)	Glucose infusion rates were adjusted every 10 minutes as necessary	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

Name	Time	Method
Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients	Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal	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.

Trial Locations

Locations (1)

Altea Therapeutics Clinical Research Center; 🇺🇸 387 Technology Circle, NW, Suite 100, Atlanta, Georgia, United States