PMID- 23398530
OWN - NLM
STAT- MEDLINE
DCOM- 20140311
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 15
IP  - 8
DP  - 2013 Aug
TI  - A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor 
      empagliflozin in patients with type 2 diabetes.
PG  - 721-8
LID - 10.1111/dom.12081 [doi]
AB  - AIM: This Phase IIb, randomized, double-blind, placebo-controlled trial evaluated 
      the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in 
      patients with type 2 diabetes. METHODS: Four hundred and eight patients 
      (treatment-naive or after a 4-week wash-out period) were randomized to receive 
      empagliflozin 5, 10 or 25 mg once daily, placebo or open-label metformin for 
      12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 
      12 weeks. RESULTS: After 12 weeks' treatment, empagliflozin showed dose-dependent 
      reductions in HbA1c from baseline [5 mg: -0.4%, 10 mg: -0.5%, 25 mg: -0.6%; all 
      doses p < 0.0001 vs. placebo (+0.09%)]. Fasting plasma glucose (FPG) decreased 
      with empagliflozin [5 mg: -1.29 mmol/l, 10 mg: -1.61 mmol/l, 25 mg: -1.72 mmol/l; 
      all doses p < 0.0001 vs. placebo (+0.04 mmol/l)]. Body weight decreased in all 
      empagliflozin groups (all doses p < 0.001 vs. placebo). The incidence of adverse 
      events (AEs) was similar in the placebo (32.9%) and empagliflozin (29.1%) groups. 
      The most frequently reported AEs on empagliflozin were pollakiuria (3.3% vs. 0% 
      for placebo), thirst (3.3% vs. 0% for placebo) and nasopharyngitis (2.0% vs. 1.2% 
      for placebo). AEs consistent with urinary tract infections (UTIs) were reported 
      in four (1.6%) patients on empagliflozin vs. one (1.2%) on placebo. Genital 
      infections were reported in five (2%) patients on empagliflozin vs. 0% on 
      placebo. No UTIs or genital infections led to premature discontinuation. 
      CONCLUSIONS: In patients with type 2 diabetes, empagliflozin resulted in 
      dose-dependent, clinically meaningful reductions in HbA1c and FPG, and reductions 
      in body weight compared with placebo. Empagliflozin was well-tolerated with a 
      favourable safety profile.
CI  - (c) 2013 Blackwell Publishing Ltd.
FAU - Ferrannini, E
AU  - Ferrannini E
AD  - Department of Internal Medicine, University of Pisa, Pisa, Italy. 
      ferranni@ifc.cnr.it
FAU - Seman, L
AU  - Seman L
FAU - Seewaldt-Becker, E
AU  - Seewaldt-Becker E
FAU - Hantel, S
AU  - Hantel S
FAU - Pinnetti, S
AU  - Pinnetti S
FAU - Woerle, H J
AU  - Woerle HJ
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130304
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 9100L32L2N (Metformin)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Argentina/epidemiology
MH  - Benzhydryl Compounds/*administration & dosage/adverse effects
MH  - Blood Glucose
MH  - Body Weight
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/epidemiology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Europe/epidemiology
MH  - Female
MH  - Glucosides/*administration & dosage/adverse effects
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Metformin/*administration & dosage
MH  - Middle Aged
MH  - Nasopharyngitis/*chemically induced/epidemiology
MH  - Republic of Korea/epidemiology
MH  - Russia/epidemiology
MH  - *Sodium-Glucose Transporter 2 Inhibitors
MH  - Taiwan/epidemiology
MH  - Thirst
MH  - Treatment Outcome
MH  - Ukraine/epidemiology
MH  - Urination Disorders/*chemically induced/epidemiology
MH  - Weight Loss
OTO - NOTNLM
OT  - BI 10773
OT  - FPG
OT  - HbA1c
OT  - SGLT2 inhibitor
OT  - body weight
OT  - empagliflozin
OT  - tolerability
EDAT- 2013/02/13 06:00
MHDA- 2014/03/13 06:00
CRDT- 2013/02/13 06:00
PHST- 2012/12/03 00:00 [received]
PHST- 2012/12/28 00:00 [revised]
PHST- 2013/02/04 00:00 [accepted]
PHST- 2013/02/13 06:00 [entrez]
PHST- 2013/02/13 06:00 [pubmed]
PHST- 2014/03/13 06:00 [medline]
AID - 10.1111/dom.12081 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2013 Aug;15(8):721-8. doi: 10.1111/dom.12081. Epub 2013 Mar 
      4.