| Outcome Measures: |
Primary: Change in plasma volume (PV), Baseline is defined as up to 3 days predose (Week -1), Baseline to Week 12 of the double-blind treatment period|Number of patients who experience at least 1 occurrence of a treatment-related adverse event, Treatment-related adverse events are adverse events with onset during the treatment phase., Day 1 to Day 85|Number of hypoglycemic events reported, Baseline is defined as up to 3 days predose (Week -1), Baseline up to Day 98|Change in electrocardiogram (ECG) parameters, Baseline is defined as up to 3 days predose (Week -1), Baseline up to Day 98|Change in blood pressure measurements, Baseline is defined as up to 3 days predose (Week -1), Baseline up to Day 98|Number of patients with physical examination findings reported as adverse events, Baseline is defined as up to 3 days predose (Week -1), Baseline up to Week 12|Change from baseline in pulse rate (beats/minute), Baseline is defined as up to 3 days predose (Week -1), Baseline up to Day 98|Change in chemistry laboratory analytes, Baseline is defined as up to 3 days predose (Week -1), Baseline up to Day 98|Change from baseline in urinalysis laboratory analytes, Baseline is defined as up to 3 days predose (Week -1), Baseline up to Day 98|Change in hematology laboratory analytes, Baseline is defined as up to 3 days predose (Week -1), Baseline up to Day 98 | Secondary: Change in PV, Baseline is defined as up to 3 days predose (Week -1), Baseline to Week 1 of the double-blind treatment period|Change in body weight, Baseline is defined as up to 3 days predose (Week -1), Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase|Change in 24-hour urine volume, Baseline is defined as up to 3 days predose (Week -1), Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase|Change in 24-hour fractional and total excretion of uric acid, Baseline is defined as up to 3 days predose (Week -1), Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase|Change in urine pH, Baseline is defined as up to 3 days predose (Week -1), Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase|Change in percent Hemoglobin A1c (HbA1c), Baseline is defined as up to 3 days predose (Week -1), Baseline to Week 12
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