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 A(1c) (HbA(1c)): 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 combination 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 HbA(1c) 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, HbA(1c), FPG, and duration of disease were 50.8 years, 24.6 kg/m(2), 8.6%, 10.1 mmol/L, and 2.2 years, respectively. Adjusted mean changes (± standard error) in HbA(1c) 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 HbA(1c) < 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.
Keywords: Pioglitazone; Type 2 diabetes mellitus; Vildagliptin.