Transdermally Delivered Human Insulin Product

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

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

Study Overview

• Status: Completed
• Conditions: Hypoinsulinemia
• Intervention / Treatment: Combination product: TD Insulin

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Palm Beach Gardens, Florida, United States, 33410
      • Langford Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 61 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Single patient, brittle T1D patient

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TD Insulin Pilot; Test of novel transdermal insulin (TD Insulin) formulations	Combination product: TD Insulin; Human Insulin USP formulated in a solution capable of transdermal delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin response	Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin	8-24 hours

Collaborators and Investigators

• Sponsor: Transdermal Delivery Solutions Corp
• Investigators: Principal Investigator: William D Kirsh, D.O., Sentry Data Systems

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2017
• Primary Completion (Actual): February 4, 2018
• Study Completion (Actual): February 4, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Insulin, needle-less, transdermal
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: TDS INS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No