Transdermal Basal Insulin Patch Study in Type 1 Diabetes

Phase 2CompletedNCT00519623

Altea Therapeutics9 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

PassPort(R) Transdermal Insulin Delivery SystemOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Altea Therapeutics Clinical Research Center

387 Technology Circle, NW, Suite 100, Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

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

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.

Time frame: Glucose infusion rates were adjusted every 10 minutes as necessary

Secondary Outcomes

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 frame: Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal

Data from ClinicalTrials.gov

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