Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
7 participants
INTERVENTIONAL
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Insulin loaded Orally Dissolved Films (insulin-ODF)
Insulin loaded Orally Dissolved Films (insulin-ODF
Human Insulin Specific RIA Kit <5uCi
NPH-Insulin Injection
Interventions
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NPH-Insulin Injection
Insulin loaded Orally Dissolved Films (insulin-ODF
Eligibility Criteria
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Inclusion Criteria
2. 18.5\<BMI\<30
Exclusion Criteria
2. Known mouth cavity, gums or gastrointestinal disease.
18 Years
50 Years
ALL
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Other Identifiers
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OFRI01-CTIL-HMO
Identifier Type: -
Identifier Source: org_study_id