Health TrialsbyHealthPanel

Dose Response Study of Transdermal Human Insulin in Patients

ConditionGlucose, High Blood
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age25-75
SponsorTransdermal Delivery Solutions Corp

About this trial

A 21-Day open label study of transdermally delivered human insulin in Type 2 Diabetics as measured by response of down modulation of glucose after dosing of Insulin as compared to historic patient response to injected insulins.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult Type 2 Diabetes Mellitus ("T2D") Patients on Insulin Replacement therapy not administered via implanted pump well-managing p.r.n as defined by serum glucose ranging between 85 and 200 mg/dL and no more than 1 hypoglycemic or serious hypoglycemic event within the last 9 months.

25 and 75 years of age, inclusive.

The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent.

The subject has a body mass index (BMI) within 18-50 kg/m2.

Disqualifiers

The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.

The subject has had more than 2 hypoglycemic events in the last month.

The subject's normal insulin dose is less than 10 and more than 200 IUs.

Subjects receiving Insulin from an implanted or external insulin pump system.

Trial design

Design model

Single group

Treatments tested in this trial

  • Human Insulin

    Biological/Vaccine

    International Unit for International Unit exchange of transdermally delivered Human Insulin for injected Human Insulin or combinations of basal and fast-acting insulins.

  • Finger-actuated, Metered Pump Sprayer

    Device

    Stock, pharmaceutical grade High Density Polyethylene (HDPE) bottle and HDPE nylon and stainless steel finger-actuated pump sprayer delivering 0.2 mL per pump.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Main ExperimentalExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Glucose Time in Range for Study Participants

Number of Participants who manage blood glucose in study participants to between 70 and 200 mg Glucose / dL.

Time frame
21 Days

Secondary outcomes

1

Avoidance of Hypoglycemia in Study Participants

Number of study participants that manage blood glucose in study participants to more than 50 mg/dL for 86% of the 21-days-on-dose of the study period

Time frame
21 days.
2

Skin Safety in Study Participants

Measure of skin irritation above level 1 - erythema \& edema - according to the The Organisation for Economic Co-operation and Development (OECD) Guideline for Testing of Chemicals No. 404, adopted 17th July, 1992: "Acute Dermal Irritation/Corrosion"

Time frame
21 days dosing plus 7 days post dose follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Transdermal Delivery Solutions Corp

Lead sponsor

Langford Research Institute, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: