PMID- 20332588
OWN - NLM
STAT- MEDLINE
DCOM- 20100907
LR  - 20221207
IS  - 1348-4540 (Electronic)
IS  - 0918-8959 (Linking)
VI  - 57
IP  - 5
DP  - 2010
TI  - Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in 
      Japanese patients with type 2 diabetes mellitus.
PG  - 383-94
AB  - Sitagliptin is an oral, potent, highly selective, once-daily DPP-4 inhibitor 
      indicated for the treatment of type 2 diabetes mellitus (T2DM). To assess the 
      dose-ranging efficacy and safety/tolerability profile of once-daily sitagliptin 
      25, 50, 100, and 200 mg in Japanese patients with T2DM. In this randomized, 
      double-blind, placebo-controlled study, 363 Japanese patients with inadequate 
      glycemic control (HbA(1c)=6.5-10%; FPG< or =270 mg/dL) were randomized 
      (1:1:1:1:1) to placebo, sitagliptin 25, 50, 100, or 200 mg q.d. for 12 weeks. The 
      primary endpoint was change from baseline in HbA(1c) at Week 12. At Week 12, 
      treatment with sitagliptin at all doses tested provided significant (p<0.001) 
      reductions in HbA(1c) (-0.69 to -1.04%) from baseline (7.49 to 7.65%) relative to 
      placebo. Sitagliptin significantly (p<0.001) reduced fasting plasma glucose (FPG; 
      -15.9 to -23.2 mg/dL) and 2-hour postprandial glucose (2-hr PPG; -40.3 to -65.0 
      mg/dL) relative to placebo, in a dose-dependent manner. At doses > or =50 mg, 
      differences in HbA(1c), FPG, and 2-hr PPG between the sitagliptin groups were not 
      statistically significant. Sitagliptin was generally well tolerated with a low 
      and similar incidence of hypoglycemia and minimal weight gain relative to 
      placebo. Treatment with sitagliptin for 12 weeks provided significant and 
      clinically meaningful reductions in HbA(1c), FPG, and 2-hr PPG across the dose 
      range studied and was generally well tolerated in Japanese patients with T2DM.
FAU - Iwamoto, Yasuhiko
AU  - Iwamoto Y
AD  - Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan.
FAU - Taniguchi, Tadaaki
AU  - Taniguchi T
FAU - Nonaka, Kenji
AU  - Nonaka K
FAU - Okamoto, Taro
AU  - Okamoto T
FAU - Okuyama, Kotoba
AU  - Okuyama K
FAU - Arjona Ferreira, Juan Camilo
AU  - Arjona Ferreira JC
FAU - Amatruda, John
AU  - Amatruda J
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100324
PL  - Japan
TA  - Endocr J
JT  - Endocrine journal
JID - 9313485
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Placebos)
RN  - 0 (Pyrazines)
RN  - 0 (Triazoles)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Area Under Curve
MH  - *Asian People
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Pyrazines/*administration & dosage
MH  - Sitagliptin Phosphate
MH  - Treatment Outcome
MH  - Triazoles/*administration & dosage
MH  - Young Adult
EDAT- 2010/03/25 06:00
MHDA- 2010/09/08 06:00
CRDT- 2010/03/25 06:00
PHST- 2010/03/25 06:00 [entrez]
PHST- 2010/03/25 06:00 [pubmed]
PHST- 2010/09/08 06:00 [medline]
AID - JST.JSTAGE/endocrj/K09E-272 [pii]
AID - 10.1507/endocrj.k09e-272 [doi]
PST - ppublish
SO  - Endocr J. 2010;57(5):383-94. doi: 10.1507/endocrj.k09e-272. Epub 2010 Mar 24.