Trial | NCT00867594  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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 Started
Jul 31
2008
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2008
Last Update
Aug 11
2011
Estimate

Drug ORMD 0801

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

Criteria 

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
No Results Posted