PMID- 25827441
OWN - NLM
STAT- MEDLINE
DCOM- 20160317
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 17
IP  - 7
DP  - 2015 Jul
TI  - Efficacy and safety of empagliflozin twice daily versus once daily in patients 
      with type 2 diabetes inadequately controlled on metformin: a 16-week, randomized, 
      placebo-controlled trial.
PG  - 699-702
LID - 10.1111/dom.12469 [doi]
AB  - Patients with type 2 diabetes mellitus (T2DM) with a glycated haemoglobin (HbA1c) 
      level >/=7 and </=10% were randomized to receive empagliflozin 12.5 mg twice daily 
      (n = 219), 25 mg once daily (n = 218), 5 mg twice daily (n = 219) or 10 mg once 
      daily (n = 220), or placebo (n = 107) as add-on to stable-dose metformin 
      immediate release (IR) twice daily for 16 weeks. The primary endpoint was change 
      from baseline in HbA1c at week 16. At week 16, change from baseline in HbA1c with 
      empagliflozin twice daily was non-inferior to empagliflozin once daily and vice 
      versa. The adjusted mean (95% confidence interval) difference in change from 
      baseline in HbA1c with empagliflozin 12.5 mg twice daily versus 25 mg once daily 
      was -0.11% (-0.26, 0.03), and with empagliflozin 5 mg twice daily versus 10 mg 
      once daily it was -0.02% (-0.16, 0.13). All empagliflozin regimens were well 
      tolerated; thus, when used as add-on to metformin IR in patients with T2DM, the 
      therapeutic effect of empagliflozin twice-daily and once-daily regimens can be 
      considered equivalent.
CI  - (c) 2015 John Wiley & Sons Ltd.
FAU - Ross, S
AU  - Ross S
AD  - LMC Endocrinology Centres, Calgary, Alberta, Canada.
FAU - Thamer, C
AU  - Thamer C
AD  - Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.
FAU - Cescutti, J
AU  - Cescutti J
AD  - Boehringer Ingelheim France S.A.S., Reims, France.
FAU - Meinicke, T
AU  - Meinicke T
AD  - Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.
FAU - Woerle, H J
AU  - Woerle HJ
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
FAU - Broedl, U C
AU  - Broedl UC
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
LA  - eng
SI  - EudraCT/EUDRACT2012-000905-53
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150513
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 9100L32L2N (Metformin)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
MH  - Adult
MH  - Benzhydryl Compounds/*administration & dosage
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Glucosides/*administration & dosage
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Metformin/*administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - empagliflozin
OT  - glycaemic control
OT  - metformin
OT  - once daily
OT  - twice daily
EDAT- 2015/04/02 06:00
MHDA- 2016/03/18 06:00
CRDT- 2015/04/02 06:00
PHST- 2014/12/15 00:00 [received]
PHST- 2015/03/19 00:00 [revised]
PHST- 2015/03/27 00:00 [accepted]
PHST- 2015/04/02 06:00 [entrez]
PHST- 2015/04/02 06:00 [pubmed]
PHST- 2016/03/18 06:00 [medline]
AID - 10.1111/dom.12469 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2015 Jul;17(7):699-702. doi: 10.1111/dom.12469. Epub 2015 
      May 13.