| Outcome Measures: |
Primary: Circulating C-peptide by iAUC of C-peptide during an IVGTT, Change in circulating C-peptide levels from baseline to end of intervention measured by iAUC of C-peptide during an IVGTT until 60th minute (second phase) with AP-325 compared to placebo, 4 weeks | Secondary: Basal insulin level, Change in basal insulin level from baseline to end of treatment, 4 weeks|C-peptide level, Change in C-peptide level from baseline to end of treatment, 4 weeks|Glucose level, Change in glucose level from baseline to end of treatment, 4 weeks|iAUC of circulating insulin (overall), Change in iAUC of circulating insulin during an IVGTT from baseline to end of treatment, 4 weeks|iAUC of C-peptide level (overall), Change in C-peptide level during an IVGTT from baseline to end of treatment, 4 weeks|iAUC of glucose level (overall), Change in iAUC of glucose level during an IVGTT from baseline to end of treatment, 4 weeks|iAUC of circulating insulin (AIR) (first 10 min), Change in iAUC of circulating insulin (AIR) during an IVGTT in the first 10 minutes from baseline to end of treatment, 4 weeks|iAUC of C-peptide (first 10 min), Change in iAUC of C-peptide during an IVGTT in the first 10 minutes from baseline to end of treatment, 4 weeks|iAUC of glucose (first 10 min), Change in iAUC of glucose during an IVGTT in the first 10 minutes from baseline to end of treatment, 4 weeks|disposition index (DI), Change in the disposition index (DI) through Minimal Model during an IVGTT from baseline to end of treatment, 4 weeks|peak insulin response, Change in peak insulin response during an IVGTT from baseline to end of treatment, 4 weeks|insulin secretion rate (ISR), Change in insulin secretion rate (ISR) during an IVGTT from baseline to end of treatment, 4 weeks|fructosamine levels, Change in 1.5-Anhydroglucitol glucose from baseline to end of treatment, 4 weeks|fructosamine levels II, Change in fructosamine level from baseline to end of treatment, 4 weeks|fructosamine levels III, Change in fasting blood glucose from baseline to end of treatment, 4 weeks|Plasma concentrations of AP-325, Change in Plasma concentrations of AP-325 at 1 hour post-dose on Days 1 and 28; pre-dose on Days 4 and 28. Accumulation of Ctrough from Day 4 to Day 28, 4 weeks|Ctrough-ss (Day 28) and the change from baseline to Day 28, Change in relationship between Ctrough-ss (Day 28) and the change from baseline to Day 28 in primary and secondary endpoints, 4 weeks
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