Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

Phase 2

Completed

• Conditions: Brittle Type I Diabetes Mellitus

• Registration Number: NCT00867594
• Lead Sponsor: Hadassah Medical Organization

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-03
• Study Start: 2008-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2009-03-22
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Type 1 diabetes mellitus
• Male or female aged 18-50 years inclusive
• Body weight between 50-100kg and BMI between 18 and 30 kg/m2
• Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia
• No other medical problems

Exclusion Criteria

• History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug
• Positive pregnancy test or lactation
• Lack of family support
• Unwilling or unable to follow the study protocol
• Concurrent medical problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes	15 days

Secondary Outcome Measures

Name	Time	Method
To determine if oral insulin is likely to improve glycemic stability assessed by the reduction of the frequency and severity of hypoglycemic episodes in people with unstable type 1 diabetes	15 days

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel