Insulin Loaded Orally Dissolved Films (Insulin-ODF)

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: Insulin loaded Orally Dissolved Films (insulin-ODF; Drug: NPH-Insulin Injection

• Registration Number: NCT01446120
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-15
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-04
• Last Update Submitted: 2011-10-04
• Study First Posted: 2011-10-05
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin loaded Orally Dissolved Films (insulin-ODF)	Insulin loaded Orally Dissolved Films (insulin-ODF	-
Human Insulin Specific RIA Kit <5uCi	NPH-Insulin Injection	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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