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
  Purpose

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.


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

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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 7
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Smokers.
  2. Known mouth cavity, gums or gastrointestinal disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01446120     History of Changes
Other Study ID Numbers: OFRI01-CTIL-HMO
Study First Received: September 15, 2011
Last Updated: October 4, 2011
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014