PMID- 23356556
OWN - NLM
STAT- MEDLINE
DCOM- 20140110
LR  - 20220408
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 15
IP  - 7
DP  - 2013 Jul
TI  - Safety, tolerability, pharmacokinetics and pharmacodynamics following 4 weeks' 
      treatment with empagliflozin once daily in patients with type 2 diabetes.
PG  - 613-21
LID - 10.1111/dom.12073 [doi]
AB  - AIM: To investigate the safety, tolerability, pharmacokinetics and 
      pharmacodynamics of empagliflozin in patients with type 2 diabetes following oral 
      administration of 10, 25 or 100 mg doses once daily over 28 days. METHODS: A 
      total of 78 patients were assigned to empagliflozin 10 mg (n = 16), 25 mg 
      (n = 16) or 100 mg (n = 30) or placebo (n = 16) for 28 days. Assessments included 
      adverse events (AEs) and pharmacokinetic and pharmacodynamic endpoints. RESULTS: 
      Empagliflozin exposure increased dose-proportionally over the dose range 10-100 
      mg and showed linear pharmacokinetics with respect to time. Urinary glucose 
      excretion (UGE) increased from baseline to day 1 by 74, 90 and 81 g with 
      empagliflozin 10, 25 and 100 mg, respectively. The increases in UGE were 
      maintained over 28 days with multiple dosing. Virtually no change in UGE was 
      observed in the placebo group. Significant reductions from baseline in mean daily 
      plasma glucose and fasting plasma glucose were observed with empagliflozin 
      compared with placebo. The incidence of AEs was similar in the empagliflozin and 
      placebo groups (50.0, 56.3 and 66.7% with empagliflozin rising doses and 62.5% 
      with placebo). The most frequently reported AEs were pollakiuria (10.3%), 
      nasopharyngitis (9.0%), constipation (9.0%) and headache (7.7%). CONCLUSIONS: 
      Oral administration of empagliflozin at doses of 10, 25 or 100 mg once daily over 
      28 days resulted in significant increases in UGE and reductions in blood glucose 
      compared with placebo, and were well tolerated in patients with type 2 diabetes.
CI  - (c) 2013 Blackwell Publishing Ltd.
FAU - Heise, T
AU  - Heise T
AD  - Profil, Hellersbergstrasse 9, Neuss, Germany. tim.heise@profil.com
FAU - Seewaldt-Becker, E
AU  - Seewaldt-Becker E
FAU - Macha, S
AU  - Macha S
FAU - Hantel, S
AU  - Hantel S
FAU - Pinnetti, S
AU  - Pinnetti S
FAU - Seman, L
AU  - Seman L
FAU - Woerle, H J
AU  - Woerle HJ
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20130217
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Membrane Transport Modulators)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Benzhydryl Compounds/*administration & dosage/adverse 
      effects/pharmacology/therapeutic use
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/urine
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Germany/epidemiology
MH  - Glucosides/*administration & dosage/adverse effects/pharmacology/therapeutic use
MH  - Glycosuria/chemically induced/epidemiology/physiopathology
MH  - Humans
MH  - Hyperglycemia/prevention & control
MH  - Hypoglycemic Agents/*administration & dosage/adverse 
      effects/pharmacology/therapeutic use
MH  - Incidence
MH  - Male
MH  - Membrane Transport Modulators/*administration & dosage/adverse 
      effects/pharmacology/therapeutic use
MH  - Middle Aged
MH  - Polyuria/epidemiology/etiology
MH  - *Sodium-Glucose Transporter 2 Inhibitors
EDAT- 2013/01/30 06:00
MHDA- 2014/01/11 06:00
CRDT- 2013/01/30 06:00
PHST- 2012/08/03 00:00 [received]
PHST- 2012/09/27 00:00 [revised]
PHST- 2012/12/28 00:00 [accepted]
PHST- 2013/01/30 06:00 [entrez]
PHST- 2013/01/30 06:00 [pubmed]
PHST- 2014/01/11 06:00 [medline]
AID - 10.1111/dom.12073 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2013 Jul;15(7):613-21. doi: 10.1111/dom.12073. Epub 2013 Feb 
      17.