PMID- 24843649
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140520
LR  - 20220311
IS  - 2040-1116 (Print)
IS  - 2040-1124 (Electronic)
IS  - 2040-1116 (Linking)
VI  - 4
IP  - 2
DP  - 2013 Mar 18
TI  - Addition of sitagliptin to ongoing metformin monotherapy improves glycemic 
      control in Japanese patients with type 2 diabetes over 52 weeks.
PG  - 174-81
LID - 10.1111/jdi.12001 [doi]
AB  - AIMS/INTRODUCTION: The efficacy and safety of sitagliptin, a highly selective 
      dipeptidyl peptidase-4 inhibitor, when added to metformin monotherapy was 
      examined in Japanese patients with type 2 diabetes. MATERIALS AND METHODS: In 
      this 52-week, add-on to metformin study, 149 patients were randomly assigned to 
      receive sitagliptin 50 mg or placebo once daily in a double-blind fashion for 
      12 weeks. Thereafter, all patients who completed the double-blind period of the 
      study received open-label sitagliptin 50 mg once daily for 40 weeks, with the 
      investigator option of increasing sitagliptin to 100 mg once daily for patients 
      who met predefined glycemic thresholds. RESULTS: After 12 weeks of treatment, the 
      mean change from baseline in glycated hemoglobin (HbA1c) significantly decreased 
      with sitagliptin relative to placebo (between-group difference [95% confidence 
      interval] = -0.7% [-0.9 to -0.5] P < 0.001). At week 12, the mean changes in 2-h 
      post-meal glucose (-2.6 mmol/L [-3.5 to -1.7]) and fasting plasma glucose 
      (-1.0 mmol/L [-1.3 to -0.6]) also decreased significantly with sitagliptin 
      relative to placebo (P < 0.001 for both). Significant improvements from baseline 
      in glycemic control were also observed in the open-label period through to week 
      52. There were no differences between treatment groups in the incidence of 
      adverse events (AEs), including hypoglycemia and predefined gastrointestinal AEs 
      (nausea, vomiting and diarrhea) during the double-blind period, with similar 
      findings in the open-label period. CONCLUSIONS: Over a period of 52 weeks, the 
      addition of sitagliptin once-daily to ongoing metformin therapy was efficacious 
      and generally well tolerated in Japanese patients with type 2 diabetes. This 
      trial was registered with ClinicalTrials.gov (no. NCT00363948).
FAU - Kadowaki, Takashi
AU  - Kadowaki T
AD  - Graduate School of Medicine The University of Tokyo Tokyo Japan.
FAU - Tajima, Naoko
AU  - Tajima N
AD  - Jikei University School of Medicine Tokyo Japan.
FAU - Odawara, Masato
AU  - Odawara M
AD  - The Third Department of Internal Medicine Tokyo Medical University Tokyo Japan.
FAU - Nishii, Mikio
AU  - Nishii M
AD  - Development Planning Ono Pharmaceutical Co., Ltd Osaka Tokyo Japan.
FAU - Taniguchi, Tadaaki
AU  - Taniguchi T
AD  - MSD K. K Tokyo Japan.
FAU - Ferreira, Juan Camilo Arjona
AU  - Ferreira JC
AD  - Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc Whitehouse Station NJ 
      USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT00363948
PT  - Journal Article
DEP - 20121022
PL  - Japan
TA  - J Diabetes Investig
JT  - Journal of diabetes investigation
JID - 101520702
PMC - PMC4019272
OTO - NOTNLM
OT  - Metformin
OT  - Sitagliptin
OT  - Type 2 diabetes
EDAT- 2013/03/18 00:00
MHDA- 2013/03/18 00:01
PMCR- 2013/03/18
CRDT- 2014/05/21 06:00
PHST- 2012/02/01 00:00 [received]
PHST- 2012/07/19 00:00 [revised]
PHST- 2012/08/06 00:00 [accepted]
PHST- 2014/05/21 06:00 [entrez]
PHST- 2013/03/18 00:00 [pubmed]
PHST- 2013/03/18 00:01 [medline]
PHST- 2013/03/18 00:00 [pmc-release]
AID - JDI12001 [pii]
AID - 10.1111/jdi.12001 [doi]
PST - ppublish
SO  - J Diabetes Investig. 2013 Mar 18;4(2):174-81. doi: 10.1111/jdi.12001. Epub 2012 
      Oct 22.