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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120912
• Other study ID #: OS-INS-P1-01
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2010
• Last updated: April 16, 2012
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Oshadi Drug Administration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Oshadi Oral Insulin
Oral insulin single administration

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Zrifin	Beer-Yaakov

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events occurrence		one month	Yes
Secondary	Evaluate the glucose lowering effect of Oshadi Oral Insulin		12 hours following administration	No