PMID- 27229178
OWN - NLM
STAT- MEDLINE
DCOM- 20170601
LR  - 20221207
IS  - 1753-0407 (Electronic)
IS  - 1753-0407 (Linking)
VI  - 9
IP  - 4
DP  - 2017 Apr
TI  - Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with 
      glimepiride in patients with type 2 diabetes: A multicenter randomized 
      double-blind study.
PG  - 412-422
LID - 10.1111/1753-0407.12432 [doi]
AB  - BACKGROUND: Early initiation of combination therapy using antihyperglycemic 
      agents is recommended for treating type 2 diabetes (T2D). The present multicenter 
      double-blind randomized parallel-group study examined the efficacy and safety of 
      a sitagliptin and metformin fixed-dose combination (Sita/Met) compared with 
      glimepiride in T2D patients as initial treatment. METHODS: Type 2 diabetes 
      patients (aged >/=18 years) were randomized to Sita/Met or glimepiride for 30 weeks 
      after a wash-off run-in period. The primary endpoint was change from baseline 
      (CFB) in HbA1c. Secondary endpoints included the proportion of patients achieving 
      target goal (HbA1c < 7.0 % [53 mmol/mol]) and CFB in fasting plasma glucose 
      (FPG). Safety assessments comprised weight gain from baseline and the incidence 
      of adverse events (AEs). RESULTS: In total, 292 patients were randomized to 
      Sita/Met (n = 147) or glimepiride (n = 145). After 30 weeks, Sita/Met 
      demonstrated superiority over glimepiride in reducing HbA1c (-1.49 % vs -0.71 %, 
      respectively; between-group difference - 0.78 %; P < 0.001). A significantly 
      higher proportion of patients achieved the target goal with Sita/Met (81.2 %) 
      than with glimepiride (40.1 %; P < 0.001). Greater reduction in FPG occurred with 
      Sita/Met than with glimepiride (least-squares mean difference - 23.5 mg/dL; 
      P < 0.001). Both drugs were generally well tolerated. Hypoglycemia events and 
      weight gain were significantly lower in patients with Sita/Met than with 
      glimepiride (5.5 % vs 20.1 % and -0.83 vs +0.90 kg, respectively; both 
      P < 0.001). No serious drug-related AEs or deaths were reported. CONCLUSIONS: 
      Compared with glimepiride, Sita/Met as an initial treatment led to significantly 
      greater improvements in glycemic control and body weight changes, with a lower 
      incidence of hypoglycemia, over 30 weeks.
CI  - (c) 2016 The Authors. Journal of Diabetes published by John Wiley & Sons Australia, 
      Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.
FAU - Kim, Sang Soo
AU  - Kim SS
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan 
      National University Hospital, Busan, South Korea.
AD  - Biomedical Research Institute, Pusan National University Hospital, Busan, South 
      Korea.
FAU - Kim, In Joo
AU  - Kim IJ
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan 
      National University Hospital, Busan, South Korea.
AD  - Biomedical Research Institute, Pusan National University Hospital, Busan, South 
      Korea.
FAU - Lee, Kwang Jae
AU  - Lee KJ
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Daedong Hospital, Busan, South Korea.
FAU - Park, Jeong Hyun
AU  - Park JH
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje 
      University Busan Paik Hospital, Inje University College of Medicine, Busan, South 
      Korea.
FAU - Kim, Young Il
AU  - Kim YI
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, Ulsan 
      University Hospital, Ulsan, South Korea.
FAU - Lee, Young Sil
AU  - Lee YS
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Dongguk University School of Medicine, Gyeongju, South Korea.
FAU - Chung, Sung Chang
AU  - Chung SC
AD  - Division of Endocrinology and Metabolism, Department of Internal Medicine, 
      Dongkang Medical Center, Ulsan, South Korea.
FAU - Lee, Sang Jin
AU  - Lee SJ
AD  - MSD Korea Ltd, Seoul, South Korea.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160808
PL  - Australia
TA  - J Diabetes
JT  - Journal of diabetes
JID - 101504326
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6KY687524K (glimepiride)
RN  - 9100L32L2N (Metformin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adult
MH  - Blood Glucose/metabolism
MH  - Body Weight/drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Diarrhea/chemically induced
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Dyspepsia/chemically induced
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/therapeutic use
MH  - Infections/chemically induced
MH  - Male
MH  - Metformin/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Sitagliptin Phosphate/adverse effects/*therapeutic use
MH  - Sulfonylurea Compounds/adverse effects/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - glimepiride
OT  - hypoglycemia
OT  - metformin
OT  - sitagliptin phosphate
OT  - 二甲双胍
OT  - 低血糖
OT  - 格列美脲
OT  - 磷酸西格列汀
EDAT- 2016/10/25 06:00
MHDA- 2017/06/02 06:00
CRDT- 2016/05/28 06:00
PHST- 2016/02/14 00:00 [received]
PHST- 2016/05/11 00:00 [revised]
PHST- 2016/05/18 00:00 [accepted]
PHST- 2016/10/25 06:00 [pubmed]
PHST- 2017/06/02 06:00 [medline]
PHST- 2016/05/28 06:00 [entrez]
AID - 10.1111/1753-0407.12432 [doi]
PST - ppublish
SO  - J Diabetes. 2017 Apr;9(4):412-422. doi: 10.1111/1753-0407.12432. Epub 2016 Aug 8.