Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients

Exclusion Criteria

• •1. Any hypersensitivity or allergy
• •2. Positive urine ketones test at screening visit.
• •3. ECG abnormality
• •4. total daily insulin \>1 IU/kg and/or \>0.7 IU/Kg of basal insulin and/or \>0.6 IU/Kg of prandial insulin.
• •5. Patient with a clinically significant abnormality
• •6. Evidence of severe secondary complications of diabetes
• •7. History of drug or alcohol dependence or abuse
• •8. Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control.
• •9. Patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study
• •10. History of two or more severe episodes of hypoglycemia (defined by ADA criteria) within 6 months prior to screening and/or patients with history of low blood glucose level episodes suggestive of hypoglycemia unawareness (loss of warning symptoms of hypoglycemia). Investigator to assess this criterion based on the subject filled questionnaire.
• •11. Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
• •12. Impaired hepatic function (ALT or AST value greater than 2 X Upper limit of reference range and/or serum bilirubin ≥1.5 X Upper limit of reference range at the screening visit).
• •13. Impaired renal function (serum creatinine ≥1.5 X Upper limit of reference range at screening).
• •14. Hemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of HbA1c.
• •15. Any electively planned surgery requiring hospitalization during the study period.
• •16. Pregnancy, lactation, or planned pregnancy during the study duration.
• •17. The patient has received another investigational drug within 6 weeks prior to screening
• •18. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.