Insulin Loaded Orally Dissolved Films (Insulin-ODF)

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Insulin loaded Orally Dissolved Films (insulin-ODF; Drug: NPH-Insulin Injection

• Study Type: Interventional
• Enrollment (Anticipated): 7
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin loaded Orally Dissolved Films (insulin-ODF)	Drug: Insulin loaded Orally Dissolved Films (insulin-ODF
Active Comparator: Human Insulin Specific RIA Kit <5uCi	Drug: NPH-Insulin Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Blood Insulin	To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.

Secondary Outcome Measures

Outcome Measure	Measure Description
glucose and C-peptide levels	Evaluating the glucose and C-peptide levels during six hours of the trial.
hypoglycemia and irritation.	All the examinations will be done in the presence of a physician along with a medical assistant. Hypoglycemia and irritation are the main adverse event that we anticipate in this study. In any such event the proper reporting and treatment will be administrated, while these subjects will be followed up for a further 1 month

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (Estimate): October 5, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: this is phase one study. The study population are healthy volunteers.
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: OFRI01-CTIL-HMO