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AIM:To assess the efficacy and safety of vildagliptin/pioglitazone combination therapy in Korean patients with type 2 diabetes mellitus(T2DM).METHODS:This was a post hoc analysis in Korean patients,from a 24-wk,randomized,active-controlled,double-blind,parallel-group,multicenter study.Eligible patients were aged between 18 and 80 years,drug naive,and had been diagnosed with T2DM [hemoglobin A1c(HbA1c):7.5-11.0 and fasting plasma glucose(FPG):< 270 mg/dL(< 15 mmol/L)].Patients were randomized(1:1:1:1) to receive the vildagliptin/pioglitazone comb ination at 100/30 mg q.d.(high-dose) or 50/15 mg q.d.(low-dose),vildagliptin 100 mg q.d.,or pioglitazone 30 mg q.d.monotherapies.The primary outcome measure was change in HbA1c from baseline to endpoint.RESULTS:The distribution of baseline demographic and clinical parameters was well balanced between treatment groups.The overall mean age,body mass index,HbA1c,FPG,and duration of disease were 50.8 years,24.6 kg/m2,8.6,10.1 mmol/L,and 2.2 years,respectively.Adjusted mean changes(± standard error) in HbA1c from baseline(~8.7) to week 24 endpoint were-2.03 ± 0.16(high-dose,N = 34),-1.88 ± 0.15(low-dose,N = 34),-1.31 ± 0.21(vildagliptin,N = 36),and-1.52 ± 0.16(pioglitazone,N = 36).The high-dose combination therapy demonstrated greater efficacy than monotherapies [vildagliptin(P = 0.029) and pioglitazone(P = 0.027)].Percentage of patients achieving HbA1c < 7 and ≤ 6.5 was the highest in the high-dose group(76 and 68) followed by low-dose(58 and 47),vildagliptin(59 and 37),and pioglitazone(53 and 28) groups.The overall incidence of adverse events was comparable.CONCLUSION:In Korean patients,first-line treatment with high-dose combination therapy improved glycemic control compared to pioglitazone and vildagliptin monotherapies,consistent with results published for the overall study population.
AIM: To assess the efficacy and safety of vildagliptin / pioglitazone combination therapy in Korean patients with type 2 diabetes mellitus (T2DM). METHODS: This was a post hoc analysis in Korean patients, from a 24-wk, randomized, active- double-blind, parallel-group, multicenter study. Eligible patients were aged between 18 and 80 years, drug naive, and had been diagnosed with T2DM [hemoglobin A1c (HbAlc): 7.5-11.0 and fasting plasma glucose (FPG): <270 Patients were randomized (1: 1: 1: 1) to receive the vildagliptin / pioglitazone comb ination at 100/30 mg qd (high-dose) or 50/15 mg qd (mg / dL low-dose), vildagliptin 100 mg qd, or pioglitazone 30 mg qdmonotherapies. The primary outcome measure was change in HbA1c from baseline to endpoint .RESULTS: The distribution of baseline demographic and clinical parameters was well balanced between treatment groups. age, body mass index, HbA1c, FPG, and duration of disease were 50.8 years, 24.6 kg / m2, 8.6, 10.1 mmol / L, and 2.2 years, r HbA1c from baseline (-8.7) to week 24 endpoint were-2.03 ± 0.16 (high-dose, N = 34), -1.8 ± 0.15 (low-dose, N = 34) , -1.31 ± 0.21 (vildagliptin, N = 36), and-1.52 ± 0.16 (pioglitazone, N = 36) .The high-dose combination demonstrated extensive efficacy than monotherapies [vildagliptin (P = 0.029) and pioglitazone ). Percentage of patients achieved HbA1c <7 and ≤ 6.5 was the highest in the high-dose group (76 and 68) followed by low-dose (58 and 47), vildagliptin (59 and 37), and pioglitazone 28) groups.The overall incidence of adverse events was comparable. CONCLUSION: In Korean patients, first-line treatment with high-dose combination therapy improved glycemic control compared to pioglitazone and vildagliptin monotherapies, consistent with results published for the overall study population.