| Outcome Measures: |
Primary: Difference in the Change From Baseline in Fasting Blood Glucose Between KQ-791 and Placebo, Data table is change from baseline in Fasting Blood Glucose. Statistical Analysis includes results for difference in Change from baseline in Fasting Blood Glucose Between KQ-791 and Placebo., Baseline to Day 29|Number of Participants With One or More Treatment-Emergent Adverse Events, Baseline to Day 29 | Secondary: Change From Baseline in the Quantitative Insulin Sensitivity Check Index (QUICKI), QUICKI = 1/(log FPG + log FPI) where FPG = fasting plasma glucose (mg/dL); FPI = fasting plasma insulin (estimated based on fasting serum insulin; (μIU/mL)). Lower numbers reflect greater insulin resistance., Baseline to Day 29|Change From Baseline in the Insulin Sensitivity Index (ISI), Insulin sensitivity index (ISI) composite using Matsuda's whole body insulin sensitivity, ISI \[composite\] = 10000/√\[(FPG x FPI)x(Mean Glucose 0-120min in MMTT x Mean Insulin 0-120 min in MMTT)\] where MMTT is a mixed meal tolerance test, Hour 0=just prior dosing. Lower values indicate greater insulin resistance., Baseline to Day 29|Change From Baseline in Beta Cell Function, Evaluated as beta index = (Insulin Area Under the Effect Curve (AUEC) in MMTT/Glucose AUEC in MMTT), Baseline to Day 29|Change From Baseline in Disposition Index, Disposition Index evaluated as beta index x ISI \[composite\]. Lower values of the disposition index suggests loss of function of beta cells., Baseline to Day 29|Change From Baseline in the Hepatic Insulin Resistance Index, Hepatic Insulin Resistance Index will be evaluated as Glucose AUEC from zero to 30 minutes (AUEC0-30min) in MMTT x Insulin AUEC0-30 min in MMTT, Baseline to Day 29|Change From Baseline in 7-point Average Blood Glucose, The 7-points measured were just prior to each meal and 90 minutes after the start of the meal and approximately bedtime., Baseline to Day 29|Change From Baseline in Postprandial Glucose, Baseline to Day 29|Change From Baseline in HbA1c, Baseline to Day 29|Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hours Post-Dose (AUC0-24), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose|Maximum Observed Plasma Concentration (Cmax), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose|Time of the Maximum Measured Plasma Concentration (Tmax), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose|Area Under the Plasma Concentration Versus Time Curve (AUCtau), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Maximum Observed Plasma Concentration at Steady-state (Cmax_ss), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Time of the Maximum Measured Plasma Concentration at Steady-state (Tmax_ss), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Apparent Terminal Elimination Half-life (t1/2), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Accumulation Index (AI), Based on AUC (RacAUC), where RacAUC is the ratio of AUC during a dosing interval following the last dose over the loading dose (first dose), Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29
|