Brittle Type I Diabetes Mellitus Clinical Trial
Official title:
A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects
| Verified date | March 2008 |
| Source | Hadassah Medical Organization |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | August 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah University Hospital | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization | Oramed Pharmaceutical Inc. |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes | 15 days | Yes | |
| Secondary | 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 | Yes |