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
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: Oshadi Oral Insulin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Oshadi Drug Administration:

Primary Outcome Measures:
  • Adverse events occurrence [ Time Frame: one month ] [ Designated as safety issue: Yes ]

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

Enrollment: 8
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral insulin and placebo Drug: Oshadi Oral Insulin
Oral insulin single administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120912

Locations
Israel
Assaf Harofe Medical Center
Zrifin, Beer-Yaakov, Israel, 70300
Sponsors and Collaborators
Oshadi Drug Administration
Investigators
Study Director: Hanna Levy, Dr. Oshadi Drug Administration
  More Information

No publications provided

Responsible Party: Oshadi Drug Administration
ClinicalTrials.gov Identifier: NCT01120912     History of Changes
Other Study ID Numbers: OS-INS-P1-01
Study First Received: May 8, 2010
Last Updated: April 16, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Oshadi Drug Administration:
oral insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014