| Outcome Measures: |
Primary: Area Under the Curve (AUC(0-16)) of Endogenous Glucose Production, The endogenous glucose production in ORMD-0801 and placebo measured by the glucose with tracer attached using AUC(0-16) as the primary parameter. The intravenous infusion of \[6,6-2H2\]-glucose tracer is administered following administraiton of either placebo or intervention. The pharmacokinetic time points are basline (pre dose), 0.75 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 4 hr, 5 hr, 6 hr, 7 hr, 8 hr, 9 hr, 10 hr, 11 hr, 12 hr, 13 hr, 14 hr, 15 hr, 16 hr post-dose., Day 28 (1 day) | Secondary: Mean Changes in HbA1c, Mean Changes of HbA1c measured in percentage of glycated hemoglobin, baseline to Day 29 of the treatment period.|Area Under the Curve AUC(0-16) of Metabolite Beta-hydroxybutyrate, AUC(0-16) measured in umol\*hr/L with blood draws at baseline ( time "0", prior to drug administration), then 45 min, 90 min, 120 min, 150 min, 3-16 hours in one-hour intervals post intervention plus tracer administration via intravenous infusion of \[6,6-2H2\]-glucose tracer. The AUC measured is AUC(0-16) where "0-16" is 0 pre-dose, 0.75 hr. 1.5 hrs, 2 hrs. 2.5 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs, 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs. post dose., Day 28|Area Under the Curve (AUC) of Insulin, The Area Under the Cuve (AUC) measured from baseline (prior to placebo, intervention, and tracer infusion) to sixteen hours post treatment andministration and tracer infusion administration. The tracer is \[6,6-2H2\]-glucose tracer using AUC(0-16). Pharmacokinetic time points are: Baseline (0 hr, pre-dose), then 0.75 hr, 1.5 hrs, 2 hrs, 2.5 hrs., 3 hrs., 4 hrs, 5 hrs, 6 hrs, 7hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs (post dose)., Day 28 (one day)|Area Under the Curve (AUC) of Free Fatty Acids (FFA), AUC measured from Baseline (prior to administration of placebo orintervention and to tracer infusion. The tracer is \[6,6-2H2\]-glucose tracer using AUC(0-16). Pharmacokinetic time points are: Baseline (0 hr, pre-dose), then 0.75 hr, 1.5 hrs, 2 hrs, 2.5 hrs., 3 hrs., 4 hrs, 5 hrs, 6 hrs, 7hrs, 8 hrs, 9 hrs, 10 hrs, 11 hrs 12 hrs, 13 hrs, 14 hrs, 15 hrs, 16 hrs (post dose)., Day 28 (one day)|Mean Changes Plasma Glucose Levels, Mean changes in plasma glucose levels measured in mg/dL. In this outcome measure, the change from baseline of mean plasma glucose for the placebo arm is calculated as: Mean Plasma Glucose (Day 29, 21 subjects) - Mean Plasma Glucose (Baseline, 21 subjects). The Baseline Mean Plasma Glucose based on 21 subjects is 192.7 mg/dL. Therefore, 192.7 mg/dL - 212.3 mg/dL = -19.6 mg./dL, baseline to Day 29 of the treatment period.
|
