Outcome Measures: |
Primary: Incidence of adverse events (AEs) and serious adverse events (SAEs), for Phase I, Week 48|Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR), or Phase II, Week 0, 24 | Secondary: Change from baseline to all post-treatment visits in creatinine, Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in blood urea nitrogen (BUN), Weeks 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in blood cystatin C, Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in urine total protein-creatinine ratio (UPCR), Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in plasma neutrophil gelatinase-associated lipocalin (NGAL) by enzyme-linked immunosorbent assay (ELISA), Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in urine kidney injury molecule-1(KIM-1), Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18), Weeks 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in urine liver-type fatty acid-binding protein (L-FABP), Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in urine neutrophil gelatinase-associated lipocalin (NGAL), Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in urine cystatin C, Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in hemoglobin A1c, Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in fasting plasma glucose, Weeks 0, 2, 4, 12, 24, 36, 48|Percentage of patients with hypoglycemia (defined as blood glucose < 55 mg/dL or 3.0 mmol/L) at all post-treatment visits, Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in body weight, Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR), Weeks 0, 2, 4, 12, 24, 36, 48|Change from baseline to all post-treatment visits in eGFR, Weeks 0, 2, 4, 12, 24, 36, 48
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