PMID- 29215189
OWN - NLM
STAT- MEDLINE
DCOM- 20181017
LR  - 20221207
IS  - 1753-0407 (Electronic)
IS  - 1753-0407 (Linking)
VI  - 10
IP  - 7
DP  - 2018 Jul
TI  - Dapagliflozin as add-on therapy in Asian patients with type 2 diabetes 
      inadequately controlled on insulin with or without oral antihyperglycemic drugs: 
      A randomized controlled trial.
PG  - 589-599
LID - 10.1111/1753-0407.12634 [doi]
AB  - BACKGROUND: This 24-week Phase 3 double-blind placebo-controlled study assessed 
      the safety and efficacy of dapagliflozin as add-on to insulin, with or without 
      oral antihyperglycemic drugs (OADs), in Asian patients with inadequately 
      controlled type 2 diabetes mellitus. METHODS: Adult patients with HbA1c between 
      >/=7.5% and </=10.5%, body mass index </=45 kg/m(2) , and on insulin doses >/=20 IU daily 
      were randomized to dapagliflozin 10 mg (n = 139) or placebo (n = 133) to assess 
      24-week changes in HbA1c (primary outcome), fasting plasma glucose (FPG), body 
      weight, total daily dose of insulin (TDDI), and seated systolic blood pressure 
      (SeSBP; exploratory outcome). RESULTS: Baseline characteristics were similar in 
      both groups. At Week 24, compared with placebo, dapagliflozin significantly 
      improved HbA1c (mean [95% confidence interval] 0.03% [-0.11, 0.17] for placebo vs 
      -0.87% [-1.00, -0.74] for dapagliflozin; between-group difference - 0.90% [-1.09, 
      -0.71], P < 0.0001]), FPG, body weight, TDDI, and SeSBP. The incidence of adverse 
      events (AEs) in the dapagliflozin and placebo groups was 80.5% and 71.2%, 
      respectively, with few patients discontinuing due to AEs (dapagliflozin, 2.2%; 
      placebo, 4.2%). The occurrence of hypoglycemia was similar in the dapagliflozin 
      and placebo groups (23.7% and 22.6%, respectively; no major events). The 
      frequency of urinary tract and genital infections was low; no deaths were 
      reported. CONCLUSIONS: Dapagliflozin as add-on to insulin, with or without OADs, 
      significantly improved glycemic control and reduced body weight and blood 
      pressure in Asian patients. Dapagliflozin was well tolerated, with a similar 
      frequency of hypoglycemia in both groups. These results support the use of 
      dapagliflozin as add-on to insulin, with or without OADs, in this population.
CI  - (c) 2017 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John 
      Wiley & Sons Australia, Ltd.
FAU - Yang, Wenying
AU  - Yang W
AD  - Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
FAU - Ma, Jianhua
AU  - Ma J
AD  - Department of Endocrinology, Nanjing First Hospital Affiliated to Nanjing Medical 
      University, Nanjing, China.
FAU - Li, Yiming
AU  - Li Y
AD  - Department of Endocrinology, Huashan Hospital Fudan University, Shanghai, China.
FAU - Li, Yanbing
AU  - Li Y
AD  - Department of Endocrinology, The Affiliated Hospital, Sun Yat-Sen University, 
      Guangzhou, China.
FAU - Zhou, Zhiguang
AU  - Zhou Z
AD  - Department of Endocrinology, The Second Xiangya Hospital of Central South 
      University, Changsha, China.
FAU - Kim, Jae Hyeon
AU  - Kim JH
AD  - Department of Endocrinology, Samsung Medical Center, Sungkyunkwan University 
      School of Medicine, Seoul, Republic of Korea.
FAU - Zhao, June
AU  - Zhao J
AD  - CVMD GMed, AstraZeneca, Gaithersburg, Maryland, USA.
FAU - Ptaszynska, Agata
AU  - Ptaszynska A
AD  - Innovative Medicines Development, Cardiovascular, Bristol-Myers Squibb, 
      Princeton, New Jersey, USA.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180125
PL  - Australia
TA  - J Diabetes
JT  - Journal of diabetes
JID - 101504326
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 1ULL0QJ8UC (dapagliflozin)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Asia/epidemiology
MH  - Benzhydryl Compounds/*therapeutic use
MH  - Biomarkers/analysis
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Glucosides/*therapeutic use
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/epidemiology/*prevention & control
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Insulin/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
OTO - NOTNLM
OT  - 2型糖尿病
OT  - Asian
OT  - dapagliflozin
OT  - insulin
OT  - type 2 diabetes
OT  - 亚洲人
OT  - 胰岛素
OT  - 达格列净
EDAT- 2017/12/08 06:00
MHDA- 2018/10/18 06:00
CRDT- 2017/12/08 06:00
PHST- 2017/08/09 00:00 [received]
PHST- 2017/10/26 00:00 [revised]
PHST- 2017/12/03 00:00 [accepted]
PHST- 2017/12/08 06:00 [pubmed]
PHST- 2018/10/18 06:00 [medline]
PHST- 2017/12/08 06:00 [entrez]
AID - 10.1111/1753-0407.12634 [doi]
PST - ppublish
SO  - J Diabetes. 2018 Jul;10(7):589-599. doi: 10.1111/1753-0407.12634. Epub 2018 Jan 
      25.