Safety and Tolerability of Oshadi Icp In Patients With Type 1 Diabetes Mellitus - Phase Ib Clinical Study

Inclusion criteria

• Type 1 diabetes mellitus (according to ADA criteria) for more than 1 year.
• Male/female 18 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 in the last 6 months
• Patients with positive HIV or HCV serology or positive HBsAg at screening.
• History or evidence of any active liver disease.
• History of epilepsy.
• One hypoglycemic seizure episode in the last six months or more than one hypoglycemic seizure episode in the last year.
• History of sever recurrent 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.
• 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, opiates, amphetamines, cocaine) at the screening.
• Mental disorders.
• Patients with poor venous access
• 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, hemoglobin, white blood cell count and differential, platelets.