Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients
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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
To determine the safety and tolerability of multi-doses of Oramed oral insulin in people with type 1 diabetes [ Time Frame: 15 days ]
Secondary Outcome Measures :
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 ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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