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

April 16, 2012 updated by: Oshadi Drug Administration

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Beer-Yaakov
      • Zrifin, Beer-Yaakov, Israel, 70300
        • Assaf Harofe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral insulin and placebo
Drug: Oshadi Oral Insulin
Oral insulin single administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events occurrence
Time Frame: one month
one month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oshadi Drug Administration

Investigators

  • Study Director: Hanna Levy, Dr., Oshadi Drug Administration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

May 8, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 11, 2010

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OS-INS-P1-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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