Insulin Loaded Orally Dissolved Films (Insulin-ODF)

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01446120
• Other study ID #: OFRI01-CTIL-HMO
• Status: Not yet recruiting
• Phase: Phase 1
• First received: September 15, 2011
• Last updated: October 4, 2011

Study information

• Verified date: October 2011
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• NPH-Insulin Injection

• Insulin loaded Orally Dissolved Films (insulin-ODF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Insulin	To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.		No
Secondary	glucose and C-peptide levels	Evaluating the glucose and C-peptide levels during six hours of the trial.		No
Secondary	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		Yes