Her hemoglobin A1c (HbA1c; normal range 4-5.6%) worsened from 8.4% to >12% 3 months after initiation of the medication (the patient had been diagnosed with type 2 diabetes in 2008 and was on vildagliptin/metformin 50/1000 mg twice daily in addition to insulin aspart 20 U 3 times daily and insulin glargine 20 units once daily; after worsening of her HbA1C, her insulin requirements increased by 50%). This evidence concerns the gene INS and type 2 diabetes mellitus.