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Insulin Loaded Orally Dissolved Films (Insulin-ODF)

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ClinicalTrials.gov Identifier: NCT01446120
Recruitment Status : Unknown
Verified October 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2011
Last Update Posted : October 5, 2011
Information provided by (Responsible Party):
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.


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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: NPH-Insulin Injection Drug: Insulin loaded Orally Dissolved Films (insulin-ODF Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 :
  1. glucose and C-peptide levels
    Evaluating the glucose and C-peptide levels during six hours of the trial.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01446120     History of Changes
Other Study ID Numbers: OFRI01-CTIL-HMO
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

Keywords provided by Hadassah Medical Organization:
this is phase one study. The study population are healthy volunteers.

Additional relevant MeSH terms:
Insulin, Globin Zinc
Isophane insulin, beef
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs