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

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: Oshadi Oral Insulin

• Registration Number: NCT01120912
• Lead Sponsor: Oshadi Drug Administration

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 available

Study Timeline

• Study First Submitted: 2010-05-08
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-11
• Study Start: 2010-10
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral insulin and placebo	Oshadi Oral Insulin	-

Primary Outcome Measures

Name	Time	Method
Adverse events occurrence	one month

Secondary Outcome Measures

Name	Time	Method
Evaluate the glucose lowering effect of Oshadi Oral Insulin	12 hours following administration

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Zrifin, Beer-Yaakov, Israel