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NCT Number: NCT00519623

Transdermal Basal Insulin Patch Study in Type 1 Diabetes

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Altea Therapeutics Clinical Research Center

387 Technology Circle, NW, Suite 100, Atlanta, Georgia, 30313, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PassPort(R) Transdermal Insulin Delivery System

Other

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.

Primary outcomes

  1. Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)

    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

    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.

  2. Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)

    Time frame: 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 outcomes

  1. Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Altea Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2007
Registry last updated
Dec 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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