Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients

Study Overview
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Brief Summary
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The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.

Official Title
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A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Oshadi Oral Insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable type I diabetes mellitus. Male/female 18 years old and up. Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation. Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements. Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation. Exclusion Criteria: Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results. Patients with positive HIV serology or positive HBsAg at screening. History or evidence of any active liver disease. C-peptide > 3 mg/ml (fasting). Hba1c<10. eGFR>60. Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study. Inability to give written informed consent. History of alcohol or drug abuse within 6 months of screening. Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening. Mental disorders. Patients with poor venous access. Significant swallowing disorders. Digestive disorders. Small bowel surgery. Mall absorption disorders.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral insulin and placebo<br> | Drug: Oshadi Oral Insulin<br>* Oral insulin single administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurrence |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the glucose lowering effect of Oshadi Oral Insulin |  | 12 hours following administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral insulin