Insulin Loaded Orally Dissolved Films (Insulin-ODF)

Hadassah Medical Center

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Insulin loaded Orally Dissolved Films (insulin-ODF; Drug: NPH-Insulin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01446120

OFRI01-CTIL-HMO

Details and patient eligibility

About

This study is assessing the pharmacokinetics efficacy and of Insulin loaded Orally Dissolved Films (insulin-ODF) treatment. The Insulin-ODF is attached to the inner tissue of the chick (buccal) , Releasing the insulin to the circulation, while the film is dissolved..

Primary endpoint:

1. The Cmax (Maximum Concentration of insulin in mg).
2. Tmax (the time to Cmax in minutes)
3. AUC (Area Under the Curve) of blood insulin levels during six hours of the trial.

Secondary endpoints:

1. The glucose and C-peptide levels during six hours of the trial. (mg)
2. The safety of the treatment in a descriptive manner by recording all adverse events in the study population.

Methods

Seven healthy volunteers will be randomly assigned to one of the following groups:

A. Insulin-ODF following treatment group; Or B. commercial NPH Insulin treatment.

The study is designed a crossover, in which each group is treated 3-7 days of washout.

The volunteer subjects will arrive to the clinic after eight hours fasting. Each subject will be examined by a physician, evaluating the elegibilities to the trial (i.e. inclusion and exclusion criteria).

An I.V catheter will be administrated assessing the Glucose, Insulin and C-peptide levels, ten minutes and five minutes before injecting the NPH Insulin or the Insulin-ODF.

Blood Insulin and glucose levels will be evaluated at baseline, and after the following time points: 15,30,60,90,120,150,180,210,240,270,300,330,360 minutes. C-peptide levels will be evaluated at baseline and after the following time points: 60,120,240, 360 minutes.

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed Informed Consent.
2. 18.5<BMI<30

Exclusion criteria

1. Smokers.
2. Known mouth cavity, gums or gastrointestinal disease.

Trial design

7 participants in 2 patient groups

Insulin loaded Orally Dissolved Films (insulin-ODF)

Experimental group

Treatment:

Drug: Insulin loaded Orally Dissolved Films (insulin-ODF

Human Insulin Specific RIA Kit <5uCi

Active Comparator group

Treatment:

Drug: NPH-Insulin Injection