PMID- 26625270
OWN - NLM
STAT- MEDLINE
DCOM- 20170418
LR  - 20221207
IS  - 1753-0407 (Electronic)
IS  - 1753-0407 (Linking)
VI  - 8
IP  - 5
DP  - 2016 Sep
TI  - A randomized clinical trial evaluating the safety and efficacy of sitagliptin 
      added to the combination of sulfonylurea and metformin in patients with type 2 
      diabetes mellitus and inadequate glycemic control.
PG  - 701-11
LID - 10.1111/1753-0407.12351 [doi]
AB  - BACKGROUND: Type 2 diabetes mellitus (T2DM) treatment generally requires multiple 
      antihyperglycemic agents. When diet, exercise, and treatment with sulfonylurea 
      and metformin do not achieve glycemic goals, several options are available. The 
      present study evaluated the efficacy and tolerability of sitagliptin 100 mg/day 
      added to therapy with sulfonylurea and metformin. METHODS: Patients with HbA1c 
      >/=7.5% and </=10.5% while on a sulfonylurea and metformin were randomized 1: 1 to 
      sitagliptin 100 mg/day or placebo for 24 weeks. At Week 24, patients in the 
      placebo group switched to pioglitazone 30 mg/day and both groups continued 
      treatment for another 30 weeks. RESULTS: Of 427 patients randomized, 339 (79.4%) 
      completed the study. At Week 24, significantly greater (P < 0.001) mean 
      reductions from baseline were seen in the sitagliptin versus placebo group for 
      HbA1c (-0.84% vs -0.16%, respectively), 2-h post-meal glucose (-2.0 vs 
      -0.2 mmol/L, respectively) and fasting plasma glucose (-0.7 vs 0.3 mmol/L, 
      respectively). At Week 54, improvements in glycemic control continued. At Week 
      24, the incidence of adverse events (AEs) was numerically greater with 
      sitagliptin than placebo, primarily because of a higher incidence of 
      hypoglycemia. At Week 54, the incidence of AEs was similar in both groups, 
      primarily because of a higher incidence of hypoglycemia and edema in the 
      placebo/pioglitazone group after Week 24. The only meaningful change in body 
      weight was an increase in the placebo/pioglitazone group at Week 54. CONCLUSIONS: 
      In this study, sitagliptin 100 mg/day was generally well tolerated and provided 
      improvement in glycemic control when added to the combination of sulfonylurea and 
      metformin in patients with T2DM.
CI  - (c) 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John 
      Wiley & Sons Australia, Ltd.
FAU - Moses, Robert G
AU  - Moses RG
AD  - Illawarra Shoalhaven Local Health District, Wollongong, New South Wales, 
      Australia.
FAU - Round, Elizabeth
AU  - Round E
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
FAU - Shentu, Yue
AU  - Shentu Y
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
FAU - Golm, Gregory T
AU  - Golm GT
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
FAU - O'neill, Edward A
AU  - O'neill EA
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
FAU - Gantz, Ira
AU  - Gantz I
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
FAU - Engel, Samuel S
AU  - Engel SS
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
FAU - Kaufman, Keith D
AU  - Kaufman KD
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
FAU - Goldstein, Barry J
AU  - Goldstein BJ
AD  - Merck & Co., Inc, Kenilworth, New Jersey, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160203
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  - 9100L32L2N (Metformin)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/*metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/therapeutic use
MH  - Male
MH  - Metformin/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Single-Blind Method
MH  - Sitagliptin Phosphate/adverse effects/*therapeutic use
MH  - Sulfonylurea Compounds/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - combination therapy
OT  - dipeptidyl peptidase-4
OT  - incretins
OT  - 二肽基肽酶
OT  - 联合治疗
OT  - 肠促胰素。
EDAT- 2015/12/02 06:00
MHDA- 2017/04/19 06:00
CRDT- 2015/12/02 06:00
PHST- 2015/08/28 00:00 [received]
PHST- 2015/11/02 00:00 [accepted]
PHST- 2015/12/02 06:00 [entrez]
PHST- 2015/12/02 06:00 [pubmed]
PHST- 2017/04/19 06:00 [medline]
AID - 10.1111/1753-0407.12351 [doi]
PST - ppublish
SO  - J Diabetes. 2016 Sep;8(5):701-11. doi: 10.1111/1753-0407.12351. Epub 2016 Feb 3.