Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

Hadassah Medical Center

Status and phase: Completed; Phase 2

Conditions: Brittle Type I Diabetes Mellitus

Treatments: Drug: ORMD 0801

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00867594

0566-08-HMO-CTIL

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)