Efficacy and safety of vildagliptin and voglibose in Japanese patients with type 2 diabetes: a 12‐week,randomized, double‐blind,active‐controlled study |
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Authors: | Y. Iwamoto A. Kashiwagi N. Yamada S. Terao N. Mimori M. Suzuki H. Tachibana |
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Affiliation: | 1. Diabetes Center, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan;2. Department of Medicine, Shiga University of Medical Science, Shiga, Japan;3. Department of Internal Medicine (Endocrinology and Metabolism), Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki, Japan;4. Novartis Pharma K.K., Tokyo, Japan |
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Abstract: | Aim: To confirm the efficacy of vildagliptin in patients with type 2 diabetes (T2D) by testing the hypothesis that glycosylated haemoglobin (HbA1c) reduction with vildagliptin is superior to that with voglibose after 12 weeks of treatment. Methods: In this 12‐week, randomized, double‐blind, active‐controlled, parallel‐group study, the efficacy and safety of vildagliptin (50 mg bid, n = 188) was compared with that of voglibose (0.2 mg tid, n = 192) in patients with T2D who were inadequately controlled with diet and exercise. Results: The characteristics of two groups were well matched at baseline. The mean age, body mass index (BMI) and HbA1c were 59.1 years, 24.9 kg/m2 and 7.6%, respectively. At baseline, fasting plasma glucose (FPG) and 2‐h postprandial glucose (PPG) were 9.01 mmol/l (162.2 mg/dl) and 13.57 mmol/l (244.3 mg/dl), respectively. The adjusted mean change in HbA1c from baseline to endpoint was ?0.95 ± 0.04% in the vildagliptin‐treated patients and ?0.38 ± 0.04% in those receiving voglibose (between‐group change = 0.57 ± 0.06%, 95% confidence interval (CI) (?0.68 to ?0.46%), p < 0.001), showing that vildagliptin was superior to voglibose. Endpoint HbA1c ≤ 6.5% was achieved in 51% vildagliptin‐treated patients compared with 24% patients who were on voglibose (p < 0.001). Vildagliptin also exhibited significantly (p < 0.001) greater reduction compared with voglibose in both FPG [1.34 vs. 0.43 mmol/l (24.1 vs. 7.8 mg/dl)] and 2‐h PPG [2.86 vs. 1.1 mmol/l (51.5 vs. 19.8 mg/dl)]. Overall adverse events (AEs) were lower in the vildagliptin‐treated patients compared with that in the voglibose‐treated patients (61.2 vs. 71.4%), with no incidence of hypoglycaemia and serious adverse events with vildagliptin. Gastrointestinal AEs were significantly lower with vildagliptin compared with that of the voglibose (18.6 vs. 32.8%; p = 0.002). Conclusions: Vildagliptin (50 mg bid) showed superior efficacy and better tolerability compared with voglibose in Japanese patients with T2D. |
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Keywords: | DPP‐4 inhibitor HbA1c type 2 diabetes mellitus vildagliptin voglibose |
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