Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized,double‐blind trial |
| |
Authors: | Y. Iwamoto N. Tajima T. Kadowaki K. Nonaka T. Taniguchi M. Nishii J. C. Arjona Ferreira J. M. Amatruda |
| |
Affiliation: | 1. Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan;2. Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan;3. Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;4. Clinical Development Institute, Banyu Pharmaceutical Co., Ltd., Tokyo, Japan;5. Development Planning, Ono Pharmaceutical Co., Ltd., Osaka, Japan;6. Merck Research Laboratories, Merck & Co., Inc., Rahway, NJ, USA |
| |
Abstract: | Objective: To compare the efficacy and safety of sitagliptin (a dipeptidyl peptidase‐4 inhibitor) and voglibose (an α‐glucosidase inhibitor) monotherapy in Japanese patients with type 2 diabetes who have inadequate glycaemic control (HbA1c ≥6.5% and <10.0%) on diet and exercise. Methods: In a multi‐center, randomized, double‐blind, parallel‐group study, 319 patients were randomized (1:1) to 12‐week treatment with sitagliptin 50 mg once daily or voglibose 0.2 mg thrice daily before meals. The primary analysis assessed whether sitagliptin was non‐inferior to voglibose in lowering HbA1c. Results: After 12 weeks, sitagliptin was non‐inferior to voglibose for HbA1c‐lowering efficacy. Furthermore, sitagliptin was superior to voglibose, providing significantly greater reductions in HbA1c from baseline [least squares mean changes in HbA1c [95% confidence intervals (CI)] = ?0.7% (?0.8 to ?0.6) and ?0.3% (?0.4 to ?0.2), respectively; between‐group difference = ?0.4% (?0.5 to ?0.3), p < 0.001]. Sitagliptin was also superior to voglibose on other key efficacy endpoints, including change from baseline in 2‐h postmeal glucose (?2.8 mmol/l vs. ?1.8 mmol/l, p < 0.001) and fasting plasma glucose (?1.1 mmol/l vs. ?0.5 mmol/l, p < 0.001). After 12 weeks, the incidences of clinical adverse experiences (AEs), drug‐related AEs and gastrointestinal AEs in the sitagliptin group (48.5, 10.4 and 18.4%, respectively) were significantly (p < 0.05) lower than those in the voglibose group (64.7, 26.3 and 34.6%, respectively). The incidences of hypoglycaemia, serious AEs and discontinuations due to AEs were low and similar in both groups. Conclusions: In Japanese patients with type 2 diabetes, once‐daily sitagliptin monotherapy showed greater efficacy and better tolerability than thrice‐daily voglibose over 12 weeks. |
| |
Keywords: | antihyperglycaemic agents dipeptidyl peptidase‐4 inhibitor DPP‐4 inhibitor α ‐glucosidase inhibitor glycaemic control incretins MK‐0431 ONO‐5435 sitagliptin voglibose |
|
|