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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00867594

Enrollment

Registered

2009-03-24

Start date

2008-07-31

Completion date

2008-08-31

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brittle Type I Diabetes Mellitus

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

Interventions

DRUGORMD 0801

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026