PMID- 19097665
OWN - NLM
STAT- MEDLINE
DCOM- 20090427
LR  - 20151119
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 83
IP  - 1
DP  - 2009 Jan
TI  - Efficacy and safety of sitagliptin in the treatment of patients with type 2 
      diabetes in China, India, and Korea.
PG  - 106-16
LID - 10.1016/j.diabres.2008.10.009 [doi]
AB  - The efficacy and safety of sitagliptin as monotherapy were evaluated in Chinese, 
      Indian, and Korean patients with type 2 diabetes inadequately controlled by diet 
      and exercise. In a randomized, placebo-controlled, double-blind, 18-week trial, 
      530 patients with HbA(1c) >or=7.5% and <or=11.0% (mean baseline 8.7%) received 
      sitagliptin 100mg once daily or placebo. Compared with placebo, sitagliptin 
      significantly (p<0.001) reduced mean HbA(1c) (-1.0%), fasting plasma glucose 
      (-1.7 mmol/L), and 2-h postprandial glucose (-3.1 mmol/L), and a significantly 
      (p<0.001) greater proportion of sitagliptin-treated versus placebo-treated 
      patients achieved HbA(1c) <7% (20.6% versus 5.3%, respectively) at study end. 
      Efficacy of sitagliptin was demonstrated in each country. Sitagliptin was 
      generally well-tolerated. Clinical adverse events (AEs) were reported in 23.3% 
      and 15.2% of sitagliptin-treated and placebo-treated patients, respectively. The 
      difference was primarily due to increased gastrointestinal AEs in the sitagliptin 
      group, most of which were mild and resolved on study drug. Serious AEs, 
      discontinuations due to AEs, and drug-related AEs occurred with a low incidence 
      in both groups. No hypoglycemia was reported. In conclusion, in this study, 
      sitagliptin monotherapy for 18 weeks significantly improved glycemic control and 
      was well-tolerated in patients with type 2 diabetes from China, India, and Korea.
FAU - Mohan, Viswanathan
AU  - Mohan V
AD  - Madras Diabetes Research Foundation & Dr. Mohan's Diabetes Specialities Centre, 
      No. 6B, Gopalapuram, Chennai 600086, India.
FAU - Yang, Wenying
AU  - Yang W
FAU - Son, Ho-Young
AU  - Son HY
FAU - Xu, Lei
AU  - Xu L
FAU - Noble, Liliane
AU  - Noble L
FAU - Langdon, Ronald B
AU  - Langdon RB
FAU - Amatruda, John M
AU  - Amatruda JM
FAU - Stein, Peter P
AU  - Stein PP
FAU - Kaufman, Keith D
AU  - Kaufman KD
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20081220
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrazines)
RN  - 0 (Triazoles)
RN  - TS63EW8X6F (Sitagliptin Phosphate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - China
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/*therapeutic use
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - India
MH  - Korea
MH  - Male
MH  - Middle Aged
MH  - Pyrazines/*therapeutic use
MH  - Sitagliptin Phosphate
MH  - Triazoles/*therapeutic use
EDAT- 2008/12/23 09:00
MHDA- 2009/04/28 09:00
CRDT- 2008/12/23 09:00
PHST- 2008/05/08 00:00 [received]
PHST- 2008/10/24 00:00 [revised]
PHST- 2008/10/28 00:00 [accepted]
PHST- 2008/12/23 09:00 [entrez]
PHST- 2008/12/23 09:00 [pubmed]
PHST- 2009/04/28 09:00 [medline]
AID - S0168-8227(08)00544-5 [pii]
AID - 10.1016/j.diabres.2008.10.009 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2009 Jan;83(1):106-16. doi: 
      10.1016/j.diabres.2008.10.009. Epub 2008 Dec 20.