PMID- 26589253
OWN - NLM
STAT- MEDLINE
DCOM- 20180130
LR  - 20220408
IS  - 1753-0407 (Electronic)
IS  - 1753-0407 (Linking)
VI  - 8
IP  - 6
DP  - 2016 Nov
TI  - Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after 
      metformin failure: A randomized controlled trial.
PG  - 796-808
LID - 10.1111/1753-0407.12357 [doi]
AB  - BACKGROUND: Dapagliflozin, a highly selective sodium-glucose cotransporter 2 
      inhibitor, reduces hyperglycemia, body weight, and blood pressure in patients 
      with type 2 diabetes (T2D). METHODS: This randomized double-blind 
      placebo-controlled parallel-group 24-week study assessed the efficacy, safety, 
      and tolerability of dapagliflozin added to metformin in Asian patients with 
      inadequately controlled T2D (HbA1c 7.5%-10.5%). Patients were randomized to 
      receive placebo (n = 145) or dapagliflozin 5 (n = 147) or 10 mg (n = 152). 
      RESULTS: Most participants were Chinese (86.0%), with a mean age of 53.8 years 
      and mean T2D duration of 4.9 years; 92.1% completed the study. Adjusted mean 
      HbA1c changes from baseline at Week 24 (primary endpoint) were -0.23%, -0.82%, 
      and -0.85% in the placebo, dapagliflozin 5 and 10 mg groups, respectively, 
      resulting in dapagliflozin 5 and 10 mg versus placebo differences of -0.59% and 
      -0.62%, respectively (both P < 0.0001). Dapagliflozin 5 and 10 mg differences 
      versus placebo were, respectively: -1.2 and -1.5 mmol/L for fasting plasma 
      glucose; -1.1 and -1.8 kg for weight; and -2.3 and -2.7 mmol/L for 2-h 
      postprandial glucose (all P <0.0001). In the placebo, dapagliflozin 5 and 10 mg 
      groups, respectively: adverse events (AEs) occurred in 52.4%, 52.4%, and 55.3% of 
      patients; serious AEs occurred in 4.1%, 2.0%, and 2.0%; urinary tract infections 
      occurred in 4.8%, 4.1%, and 6.6%; and genital infections occurred in 0%, 2.0%, 
      and 1.3%. No AEs of pyelonephritis or renal failure occurred. CONCLUSIONS: 
      Dapagliflozin 5 or 10 mg as add-on to metformin was well tolerated in Asian 
      patients with T2D and significantly improved glycemic control with the additional 
      benefit of weight reduction.
CI  - (c) 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John 
      Wiley & Sons Australia, Ltd.
FAU - Yang, Wenying
AU  - Yang W
AD  - China-Japan Friendship Hospital, Beijing. ywying_1010@163.com.
FAU - Han, Ping
AU  - Han P
AD  - ShengJing Hospital of China Medical University, Shenyang, China.
FAU - Min, Kyung-Wan
AU  - Min KW
AD  - Eulji Hospital, Seoul, South Korea.
FAU - Wang, Bei
AU  - Wang B
AD  - Bristol-Myers Squibb, Shanghai.
FAU - Mansfield, Traci
AU  - Mansfield T
AD  - Bristol-Myers Squibb, Princeton, New Jersey, USA.
FAU - T'Joen, Caroline
AU  - T'Joen C
AD  - Bristol-Myers Squibb, Braine-l'Alleud, Belgium.
FAU - Iqbal, Nayyar
AU  - Iqbal N
AD  - Bristol-Myers Squibb, Princeton, New Jersey, USA.
FAU - Johnsson, Eva
AU  - Johnsson E
AD  - AstraZeneca, Gothenburg, Sweden.
FAU - Ptaszynska, Agata
AU  - Ptaszynska A
AD  - Bristol-Myers Squibb, Princeton, New Jersey, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160109
PL  - Australia
TA  - J Diabetes
JT  - Journal of diabetes
JID - 101504326
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Placebos)
RN  - 1ULL0QJ8UC (dapagliflozin)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adult
MH  - Benzhydryl Compounds/adverse effects/pharmacology/*therapeutic use
MH  - Blood Glucose/analysis
MH  - Blood Pressure/drug effects
MH  - Body Weight/drug effects
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Glucosides/adverse effects/pharmacology/*therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/pharmacology/*therapeutic use
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Middle Aged
MH  - Placebos
OTO - NOTNLM
OT  - Asian
OT  - dapagliflozin
OT  - treatment efficacy
OT  - 亚洲
OT  - 疗效
OT  - 达格列净
EDAT- 2015/11/22 06:00
MHDA- 2018/01/31 06:00
CRDT- 2015/11/22 06:00
PHST- 2015/06/30 00:00 [received]
PHST- 2015/11/03 00:00 [revised]
PHST- 2015/11/10 00:00 [accepted]
PHST- 2015/11/22 06:00 [pubmed]
PHST- 2018/01/31 06:00 [medline]
PHST- 2015/11/22 06:00 [entrez]
AID - 10.1111/1753-0407.12357 [doi]
PST - ppublish
SO  - J Diabetes. 2016 Nov;8(6):796-808. doi: 10.1111/1753-0407.12357. Epub 2016 Jan 9.