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

NCT ID: NCT01120912

Last Updated: 2012-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-02-28

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.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oral insulin and placebo

Group Type: EXPERIMENTAL

Oshadi Oral Insulin

Intervention Type: DRUG

Oral insulin single administration

Interventions

Oshadi Oral Insulin

Oral insulin single administration

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oshadi Drug Administration

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanna Levy, Dr.

Role: STUDY_DIRECTOR

Oshadi Drug Administration

Locations

Assaf Harofe Medical Center

Zrifin, Beer-Yaakov, Israel

Countries

Israel

Other Identifiers

OS-INS-P1-01

Identifier Type: -

Identifier Source: org_study_id