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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01120912
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : April 17, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Oshadi Oral Insulin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : October 2010
Primary Completion Date : February 2011
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oral insulin and placebo Drug: Oshadi Oral Insulin
Oral insulin single administration



Primary Outcome Measures :
  1. Adverse events occurrence [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Evaluate the glucose lowering effect of Oshadi Oral Insulin [ Time Frame: 12 hours following administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Oshadi Drug Administration
ClinicalTrials.gov Identifier: NCT01120912     History of Changes
Other Study ID Numbers: OS-INS-P1-01
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: April 17, 2012
Last Verified: February 2011

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