Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

Hadassah Medical Organization12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brittle Type I Diabetes Mellitus

Interventions

ORMD 0801DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Hadassah University Hospital

Jerusalem, Israel

Outcomes

Primary Outcomes

To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes

Time frame: 15 days

Secondary Outcomes

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

Time frame: 15 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.