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

NCT01120912 | Completed Phase 1

• 1 other identifier: OS-INS-P1-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

oral insulin

Outcome Measures

Primary Outcomes (1)

• Adverse events occurrence

  one month

Secondary Outcomes (1)

• Evaluate the glucose lowering effect of Oshadi Oral Insulin

  12 hours following administration

Study Arms (1)

Oral insulin and placebo

EXPERIMENTAL

Drug: Oshadi Oral Insulin

Interventions

Oshadi Oral Insulin DRUG

Oral insulin single administration

Oral insulin and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oshadi Drug Administration: lead

Study Sites (1)

Assaf Harofe Medical Center

Zrifin, Beer-Yaakov, 70300, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hanna Levy, Dr.

  Oshadi Drug Administration

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2010
• First Posted: May 11, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 17, 2012

Record last verified: 2011-02

Locations

IL (1)