Transdermal Basal Insulin Patch Study in Type 1 Diabetes

Altea Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 1 Diabetes

Treatments: Other: PassPort(R) Transdermal Insulin Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519623

IN2007001

Details and patient eligibility

About

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

Full 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

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

PassPort(R) Transdermal Insulin Delivery System

Experimental group

Treatment:

Other: PassPort(R) Transdermal Insulin Delivery System