Insulin Loaded Orally Dissolved Films (Insulin-ODF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01446120
First received: September 15, 2011
Last updated: October 4, 2011
Last verified: October 2011

September 15, 2011
October 4, 2011
Not Provided
Not Provided
Blood Insulin [ Designated as safety issue: No ]
To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.
Same as current
Complete list of historical versions of study NCT01446120 on ClinicalTrials.gov Archive Site
  • glucose and C-peptide levels [ Designated as safety issue: No ]
    Evaluating the glucose and C-peptide levels during six hours of the trial.
  • hypoglycemia and irritation. [ Designated as safety issue: Yes ]
    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
Same as current
Not Provided
Not Provided
 
Insulin Loaded Orally Dissolved Films (Insulin-ODF)
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteers
  • Drug: NPH-Insulin Injection
  • Drug: Insulin loaded Orally Dissolved Films (insulin-ODF
  • Experimental: Insulin loaded Orally Dissolved Films (insulin-ODF)
    Intervention: Drug: Insulin loaded Orally Dissolved Films (insulin-ODF
  • Active Comparator: Human Insulin Specific RIA Kit <5uCi
    Intervention: Drug: NPH-Insulin Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
7
Not Provided
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  1. Smokers.
  2. Known mouth cavity, gums or gastrointestinal disease.
Both
18 Years to 50 Years
Yes
Not Provided
Not Provided
 
NCT01446120
OFRI01-CTIL-HMO
No
Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Not Provided
Hadassah Medical Organization
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP