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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

May 8, 2010
April 16, 2012
October 2010
February 2011   (final data collection date for primary outcome measure)
Adverse events occurrence [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01120912 on ClinicalTrials.gov Archive Site
Evaluate the glucose lowering effect of Oshadi Oral Insulin [ Time Frame: 12 hours following administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Diabetes
Drug: Oshadi Oral Insulin
Oral insulin single administration
Experimental: Oral insulin and placebo
Intervention: Drug: Oshadi Oral Insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01120912
OS-INS-P1-01
No
Oshadi Drug Administration
Oshadi Drug Administration
Not Provided
Study Director: Hanna Levy, Dr. Oshadi Drug Administration
Oshadi Drug Administration
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP