Efficacy Safety and Tolerability of Multiple Doses of Oshadi Icp (Oshadi Oral Insulin) in Patients With Type 1 Diabetes Mellitus - Phase II Clinical Study

Inclusion criteria

• Type 1 diabetes mellitus (according to ADA criteria) for more than 3 year.
• Male/female 21 years old and older.
• BMI≥18.5 and ≤25
• Female of childbearing age must commit to avoid pregnancy and use contraception during the study.
• Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.

Exclusion criteria

• Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
• Symptomatic DKA (diabetic ketoacidosis)in the last 6 months
• Patients with positive HIV or HCV (hepatitis C virus)serology or positive HBsAg at screening.
• History or evidence of any active liver disease.
• History of epilepsy.
• One or more episodes of sever hypoglycemia during the last 12 months
• History of hypoglycemic unawareness.
• C-peptide >3 mg/ml (fasting)
• Total average daily insulin dosage ≥1 IU/kg of body weight.
• Polycystic ovary syndrome
• Acanthosis nigricans
• 6.5% > HbA1c or HbA1c >10%
• eGFR<60 (epidermal growth factor receptor).
• Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study and not willing to practice birth control during study period.
• Inability to give written informed consent
• History of alcohol or drug abuse within 6 months of screening.
• Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC (tetrahydrocannabinol), opiates, amphetamines, cocaine) at the screening.
• Mental disorders.
• Significant swallowing disorders
• Digestive disorders
• Small bowel surgery
• Any intercurrent disease during the last week prior to screening which in the judgment of the investigator might affect blood glucose level.
• Any infectious disease developed during the 4 weeks prior to the study.
• Malabsorption disorders.
• Any significant abnormality by principal investigator in the baseline laboratory evaluation: liver and kidney functions, electrolytes, albumin, lipase, TSH (thyroid-stimulating hormone), hemoglobin, white blood cell count and differential, platelets.