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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
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 15, 2011
First Posted Date  ICMJE October 5, 2011
Last Update Posted Date October 5, 2011
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
Blood Insulin
To assess the Cmax , Tmax and AUC (Area Under the Curve) of blood insulin level during six hours of the trial.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin Loaded Orally Dissolved Films (Insulin-ODF)
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: NPH-Insulin Injection
  • Drug: Insulin loaded Orally Dissolved Films (insulin-ODF
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 4, 2011)
7
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Smokers.
  2. Known mouth cavity, gums or gastrointestinal disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01446120
Other Study ID Numbers  ICMJE OFRI01-CTIL-HMO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date October 2011

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