title: 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.
abstract: 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).
  
  
  
  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.
  
  
  
  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 <7.0% (53 mmol/mol) at week 26 [odds ratio 3.65 (95% CI 2.18, 6.12); p < 0.0001]. Reductions in fasting plasma glucose, 7-point self-measured plasma glucose and body weight were greater with liraglutide than with sitagliptin (p < 0.0001 for all). More patients experienced nausea (14.8% vs 0.5%), diarrhoea (8.2% vs 2.2%) and decreased appetite (10.9% vs 0.5%) with liraglutide than sitagliptin. Two hypoglycaemic episodes were confirmed for liraglutide and one for sitagliptin; none were severe or nocturnal.
  
  
  
  Liraglutide provided better glycaemic control and greater body weight reduction than sitagliptin when administered as add-on to metformin. More patients had nausea, diarrhoea and decreased appetite with liraglutide versus sitagliptin.
authors.affiliation: Department of Endocrinology, Chinese PLA General Hospital, Beijing, China.
authors.forename: L
authors.initials: L
authors.lastname: Zang
authors.affiliation: Department of Endocrinology, Second Hospital of Jilin University, Jilin, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Endocrinology, Harrison International Peace Hospital, Hengshui, China.
authors.forename: J
authors.initials: J
authors.lastname: Geng
authors.affiliation: Department of Endocrinology, Chongqing Three Gorges Central Hospital, Chongqing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Luo
authors.affiliation: Department of Endocrinology, Cangzhou People's Hospital, Cangzhou, China.
authors.forename: F
authors.initials: F
authors.lastname: Bian
authors.affiliation: Department of Endocrinology, PLA, Military General Hospital of Beijing, Beijing, China.
authors.forename: X
authors.initials: X
authors.lastname: Lv
authors.affiliation: Department of Endocrinology, Central Hospital of Minhang District, Shanghai, China.
authors.forename: J
authors.initials: J
authors.lastname: Yang
authors.affiliation: Department of Endocrinology, Fifth People's Hospital of Shanghai, Shanghai, China.
authors.forename: J
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department of Endocrinology, Shanghai First People's Hospital, Shanghai, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Peng
authors.affiliation: Department of Endocrinology, Third Hospital of Hebei Medical University, Shijiazhuang, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Li
authors.affiliation: Novo Nordisk (China) Pharmaceuticals Co., Ltd, Beijing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Novo Nordisk A/S, Copenhagen, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Bosch-Traberg
authors.affiliation: Department of Endocrinology, Chinese PLA General Hospital, Beijing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Mu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D003967:Diarrhea / Q000139:chemically induced; D004359:Drug Therapy, Combination; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D000069450:Liraglutide / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D000068900:Sitagliptin Phosphate / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069450:Liraglutide; D008687:Metformin; D000068900:Sitagliptin Phosphate; C517652:hemoglobin A1c protein, human
keywords: Chinese; liraglutide; sitagliptin; type 2 diabetes