A Study to Compare ORMD-0801 Once Daily to ORMD-0801 Three Times Daily in Subjects With Type 1 Diabetes

Inclusion Criteria

• Male and female subjects aged 18 and older.
• Body mass index (BMI) of 19-30 kg/m2 at Screening and stable weight, with no more than 5 kg gain or loss in the 3 months prior to Screening.
• T1D subjects must have:
• A documented history of type 1 diabetes for at least 6 months
• Should be on an MDI regimen
• C peptide levels of ˂ 0.7 ng/mL
• HbA1C ≥ 6.5% to ≤10%
• Females of childbearing potential must have a negative serum pregnancy test result at Screening.
• Females who are not of childbearing potential are defined as:
• post-menopausal (defined as at least 12 months with no menses in women ≥45 years of age) or
• has had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to Screening
• Subjects who are of childbearing potential must:

a. agree to remain abstinent from heterosexual activity† or agree to use (or have their partner use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 14 days after the last dose of blinded investigational product. Two methods of contraception will be used to avoid pregnancy. Acceptable combinations of methods include: i. Use of one of the following double-barrier methods: diaphragm with spermicide and a condom; cervical cap and a condom; or a contraceptive sponge and condom ii. Use of hormonal contraception (any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent [including oral, subcutaneous, intrauterine and intramuscular agents, and cutaneous patch]) with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or IUD. iii. Use of an IUD with one of the following: condom; diaphragm with spermicide; contraceptive sponge; vasectomy; or hormonal contraception (see above).

iv. Vasectomy with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; IUD; or hormonal contraception (see above).

†Abstinence can be used as the sole method of contraception if it is in line with the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.

Exclusion Criteria

• Clinical diagnosis of type 2 diabetes;
• Evidence of unawareness of hypoglycemia unawareness, a documented plasma glucose ≤50 mg/dL in the absence of symptoms of hypoglycemia at Screening.
• FPG >300 mg/dL at Screening; a single repeat test is allowable.
• Use of the following medications:
• Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within 6 weeks prior to Screening.
• Administration of systemic long-acting corticosteroids within two months or prolonged use (more than one week) of other systemic corticosteroids or inhaled corticosteroids (if daily dosage is > 1,000 μg equivalent beclomethasone) within 30 days prior to Screening. Intra-articular and/or topical corticosteroids are not considered systemic.
• Laboratory abnormalities at Screening including:
• Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X the upper limit of normal
• Elevated liver enzymes (alanine transaminase (ALT), alanine aminotransferase (AST), alkaline phosphatase) >2X the upper limit of normal.
• Very high triglyceride levels (>600 mg/dL); a single repeat test is allowable.
• Any relevant abnormality that would interfere with the efficacy or the safety assessments during study treatment administration.
• Subject has a Screening systolic blood pressure ≥165 mmHg or diastolic blood pressure ≥100 mmHg. Subjects will be allowed to take a BP rescue medication.
• Any clinically significant ECG abnormality at Screening or cardiovascular disease. Clinically significant cardiovascular disease will inc