| Outcome Measures: |
Primary: Mean change from baseline (Visit 1) in A1C at 26 weeks, • Means and mean changes from baseline over time for A1C and FPG during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period., 6 months with follow-up extension for additional six months | Secondary: Safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects, • Safety assessed by adverse event reporting including adverse events of special interest such as hypoglycemia., 6 months with follow-up extension for additional six months | Other: Change from baseline (Visit 1) in CGM-parameters (using a FreeStyle Libre), • Change from baseline (Visit 1) in CGM-parameters at 6 months o Mean Sensor Glucose, BG SD, BG CV, Time in range (TIR)-BG 70-180 mg/dL; BG 54-69 mg/dL, BG \<54 mg/dL, BG 181-250 mg/dL, and BG \>250 mg/dL., 6 months with follow-up extension for additional six months|Proportion of subjects achieving A1C < 8%, • Proportion of subjects achieving A1C \< 8% at 6 months, 6 months with follow-up extension for additional six months|Proportion of subjects achieving A1C < 7%, • Proportion of subjects achieving A1C \< 7% at 6 months without reported severe hypoglycemic events., 6 months with follow-up extension for additional six months|Proportion of subjects requiring glycemic rescue therapy, • Proportion of subjects requiring glycemic rescue therapy and the time to rescue during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period., 6 months with follow-up extension for additional six months|Change in weight from baseline, • Change in weight from baseline during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period (in KG), 6 months with follow-up extension for additional six months|Means and mean changes from baseline over time for C-peptide, Means and mean changes from baseline over time for C-peptide during the Double-Blind Treatment Period and the Double-Blind Treatment Extension Period, 6 months with follow-up extension for additional six months
|
