NCT00867594

Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ORMD 0801	1 capsule ORMD 0801 3 times a day, before each meal

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2009-03-24
• Last updated: 2011-08-11

Locations

1 site across 1 country: Israel