controlled period, followed by a 40-week, blinded active controlled extension period (placebo switched to linagliptin). a total of 132 patients with moderate or severe ri were randomized to receive gemigliptin (n=66) or placebo (n=66). insulin was used as predominant background therapy (63.1%). at week 12, the placebo-adjusted mean change in hba1c from the baseline was –1.20% (95% ci, –1.53 to –0.87; p<0.0001). a similar profile was also observed in other glycemic control parameters (fasting plasma glucose, glycated albumin, and fructosamine). effects on glycemic variability glycemic variability and chronic sustained hyperglycemia are the main components of dysglycemia in diabetes. the previous studies suggested that different pharmacodynamic profiles between dpp-4 inhibitors have been associated with the different effects on glycemic variability. in this study, a multicenter, randomized, active-controlled, parallel group, open-label, exploratory study was designed to evaluate the efficacy on glycemic variability and safety of initial combination therapy of gemigliptin 50 mg qd versus sitagliptin 100 mg qd, or glimepiride 2 mg qd with metformin in patients with t2dm (study identifier: lg-dpcl012, stable study; clinicaltrials.gov registration number: nct01890629). the mean amplitude of glycemic excursions (mage) and sd of glucose were used for assessing glucose fluctuations from the baseline after 12 weeks of treatment. at 12 weeks, mage was significantly lower in the dpp-4 inhibitor groups (gemigliptin and sitagliptin) than in the glimepiride group (–43.1, –38.3, and –21.7 mg/dl, respectively). furthermore, the sd of mean glucose was significantly lower in patients with gemigliptin when compared with sitagliptin (p=0.023) and glimepiride (p=0.0058). ongoing studies several clinical studies in lg life sciences are actively underway to assess the efficacy and safety as an add-on combination therapy with insulin (with or without metformin) (clinicaltrials.gov registration number: nct02831361), to evaluate the efficacy and safety of gemigliptin-rosuvastatin fixed-dose combination in patients with t2dm and dyslipidemia in phase iii clinical trials (clinicaltrials.gov registration number: nct02126358), and to evaluate the efficacy and safety of gemigliptin compared with vildagliptin in russian patients with t2dm (clinicaltrials.gov registration number: nct02343926).