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Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

NCT00867594 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-08-11

No results posted yet for this study

Summary

The intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia

Conditions

  • Brittle Type I Diabetes Mellitus

Interventions

DRUG

ORMD 0801

1 capsule ORMD 0801 3 times a day, before each meal

Sponsors & Collaborators

  • Oramed Pharmaceutical Inc.

    collaborator INDUSTRY

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Roy Eldor · Hadassah

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00867594 on ClinicalTrials.gov