Skip to main content
OpenTrials
Completed

NCT Number: NCT03544996

Transdermally Delivered Human Insulin Product

An Early Feasibility Study of a device formulation to deliver human insulin across intact skin

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoinsulinemia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year–61 year

Sex eligibility

Male

Study type

Observational

Primary location

Langford Research Institute

Palm Beach Gardens, Florida, 33410, United States

About this study

An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient.

A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day

Exclusion criteria

  • High insulin sensitivity
  • well managed serum glucose

Treatment and study plan

TD Insulin

Combination Product

Human Insulin USP formulated in a solution capable of transdermal delivery.

Primary outcomes

  1. Insulin response

    Time frame: 8-24 hours

    Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin

Sponsors and collaborators

Lead sponsor

Transdermal Delivery Solutions Corp

Industry

Registry information

Official study title

A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jun 6, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.