Diabetes, Obesity and Metabolism 18: 803–811, 2016. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial L. Zang1 , Y. Liu2 , J. Geng3 , Y. Luo4 , F. Bian5 , X. Lv6 , J. Yang7 , J. Liu8 , Y. Peng9 , Y. Li10 , Y. Sun11 , H. Bosch-Traberg12 & Y. Mu1 1 Department of Endocrinology, Chinese PLA General Hospital, Beijing, China 2 Department of Endocrinology, Second Hospital of Jilin University, Jilin, China 3 Department of Endocrinology, Harrison International Peace Hospital, Hengshui, China 4 Department of Endocrinology, Chongqing Three Gorges Central Hospital, Chongqing, China 5 Department of Endocrinology, Cangzhou People’s Hospital, Cangzhou, China 6 Department of Endocrinology, PLA, Military General Hospital of Beijing, Beijing, China 7 Department of Endocrinology, Central Hospital of Minhang District, Shanghai, China 8 Department of Endocrinology, Fifth People’s Hospital of Shanghai, Shanghai, China 9 Department of Endocrinology, Shanghai First People’s Hospital, Shanghai, China 10 Department of Endocrinology, Third Hospital of Hebei Medical University, Shijiazhuang, China 11 Novo Nordisk (China) Pharmaceuticals Co., Ltd, Beijing, China 12 Novo Nordisk A/S, Copenhagen, Denmark
Aims: To compare the efficacy and safety of liraglutide versus sitagliptin as add-on to metformin after 26 weeks of treatment in Chinese patients with type 2 diabetes mellitus (T2DM). Methods: This 26-week open-label, active comparator trial (NCT02008682) randomized patients (aged 18–80 years) with T2DM inadequately controlled with metformin [glycated haemoglobin (HbA1c) 7.0–10.0% (53–86 mmol/mol)] 1 : 1 to once-daily subcutaneously administered liraglutide 1.8 mg (n = 184) or once-daily oral sitagliptin 100 mg (n = 184), both as add-on to metformin. The primary endpoint was change in HbA1c from baseline to week 26. Results: Liraglutide was superior to sitagliptin in reducing HbA1c from baseline [8.1% (65 mmol/mol)] to 26 weeks, as evidenced by estimated mean HbA1c change of −1.65% (−18.07 mmol/mol) versus −0.98% (−10.72 mmol/mol), respectively [estimated treatment difference for liraglutide vs sitagliptin of −0.67% (95% CI −0.86, −0.48) or −7.35 mmol/mol (95% CI −9.43; −5.26); p < 0.0001]. More patients receiving liraglutide (76.5%) than sitagliptin (52.6%) achieved the HbA1c target of
Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial L. Zang1 , Y. Liu2 , J. Geng3 , Y. Luo4 , F. Bian5 , X. Lv6 , J. Yang7 , J. Liu8 , Y. Peng9 , Y. Li10 , Y. Sun11 , H. Bosch-Traberg12 & Y. Mu1 1 Department of Endocrinology, Chinese PLA General Hospital, Beijing, China 2 Department of Endocrinology, Second Hospital of Jilin University, Jilin, China 3 Department of Endocrinology, Harrison International Peace Hospital, Hengshui, China 4 Department of Endocrinology, Chongqing Three Gorges Central Hospital, Chongqing, China 5 Department of Endocrinology, Cangzhou People’s Hospital, Cangzhou, China 6 Department of Endocrinology, PLA, Military General Hospital of Beijing, Beijing, China 7 Department of Endocrinology, Central Hospital of Minhang District, Shanghai, China 8 Department of Endocrinology, Fifth People’s Hospital of Shanghai, Shanghai, China 9 Department of Endocrinology, Shanghai First People’s Hospital, Shanghai, China 10 Department of Endocrinology, Third Hospital of Hebei Medical University, Shijiazhuang, China 11 Novo Nordisk (China) Pharmaceuticals Co., Ltd, Beijing, China 12 Novo Nordisk A/S, Copenhagen, Denmark
Aims: To compare the efficacy and safety of liraglutide versus sitagliptin as add-on to metformin after 26 weeks of treatment in Chinese patients with type 2 diabetes mellitus (T2DM). Methods: This 26-week open-label, active comparator trial (NCT02008682) randomized patients (aged 18–80 years) with T2DM inadequately controlled with metformin [glycated haemoglobin (HbA1c) 7.0–10.0% (53–86 mmol/mol)] 1 : 1 to once-daily subcutaneously administered liraglutide 1.8 mg (n = 184) or once-daily oral sitagliptin 100 mg (n = 184), both as add-on to metformin. The primary endpoint was change in HbA1c from baseline to week 26. Results: Liraglutide was superior to sitagliptin in reducing HbA1c from baseline [8.1% (65 mmol/mol)] to 26 weeks, as evidenced by estimated mean HbA1c change of −1.65% (−18.07 mmol/mol) versus −0.98% (−10.72 mmol/mol), respectively [estimated treatment difference for liraglutide vs sitagliptin of −0.67% (95% CI −0.86, −0.48) or −7.35 mmol/mol (95% CI −9.43; −5.26); p < 0.0001]. More patients receiving liraglutide (76.5%) than sitagliptin (52.6%) achieved the HbA1c target of
