Skip to main content
OpenTrials
Completed

NCT Number: NCT00867594

Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brittle Type I Diabetes Mellitus

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hadassah University Hospital

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORMD 0801

Drug

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Oramed Pharmaceutical Inc.

Registry information

Official study title

A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 24, 2009
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.