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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Oshadi Drug Administration

ClinicalTrials.gov Identifier:

NCT01120912

First received: May 8, 2010

Last updated: April 16, 2012

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2010

Last Updated Date

April 16, 2012

Start Date ^ICMJE

October 2010

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse events occurrence [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01120912 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the glucose lowering effect of Oshadi Oral Insulin [ Time Frame: 12 hours following administration ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

Drug: Oshadi Oral Insulin

Oral insulin single administration

Study Arm (s)

Experimental: Oral insulin and placebo

Intervention: Drug: Oshadi Oral Insulin

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

Completed

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01120912

Other Study ID Numbers ^ICMJE

OS-INS-P1-01

Has Data Monitoring Committee

Responsible Party

Oshadi Drug Administration

Study Sponsor ^ICMJE

Oshadi Drug Administration

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hanna Levy, Dr.

Oshadi Drug Administration

Information Provided By

Oshadi Drug Administration

Verification Date

February 2011

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

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