Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Brittle Type I Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ORMD 0801

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No