PMID- 24958326
OWN - NLM
STAT- MEDLINE
DCOM- 20160323
LR  - 20221207
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 31
IP  - 6
DP  - 2014 Jun
TI  - Empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 
      randomized, 12-week, double-blind, placebo-controlled, phase II trial.
PG  - 621-38
LID - 10.1007/s12325-014-0126-8 [doi]
AB  - INTRODUCTION: This study was designed to determine the efficacy and tolerability 
      of empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus 
      (T2DM). METHODS: Patients with glycosylated hemoglobin (HbA1c) >/= 7.0 - </= 10% were 
      randomized via an interactive web response system, and treated double-blind with 
      empagliflozin 5, 10, 25, 50 mg, or placebo once daily for 12 weeks. The primary 
      endpoint was change from baseline in HbA1c at week 12. Other endpoints included 
      percentage of patients with HbA1c <7.0% and changes from baseline in fasting 
      plasma glucose (FPG), body weight, and systolic blood pressure (SBP) at week 12. 
      RESULTS: A total of 547 patients were randomized and treated with empagliflozin 5 
      mg (n = 110), 10 mg (n = 109), 25 mg (n = 109), 50 mg (n = 110), or placebo (n = 
      109) for 12 weeks. Adjusted mean [95% confidence interval (CI)] differences vs. 
      placebo in changes from baseline in HbA1c were -0.72% (-0.87, -0.57) with 
      empagliflozin 5 mg, -0.70% (-0.85, -0.55) with 10 mg, -0.95% (-1.10, -0.80) with 
      25 mg, and -0.91 (-1.06, -0.76) with 50 mg (all p < 0.001). More patients with 
      HbA1c >/= 7.0% at baseline reached HbA1c <7.0% with empagliflozin (19-33%) than 
      placebo (3%). Compared with placebo, empagliflozin reduced FPG, body weight (p < 
      0.001 for all doses for both endpoints) and SBP (p = 0.001, p = 0.014 and p = 
      0.003 for empagliflozin 10, 25, and 50 mg, respectively). Adverse events were 
      reported by 42% of patients receiving placebo and 33-38% of patients receiving 
      empagliflozin. There were few reports of confirmed hypoglycemic adverse events or 
      events consistent with urinary tract infection or genital infection in any 
      treatment group. CONCLUSIONS: Empagliflozin monotherapy for 12 weeks in Japanese 
      patients with T2DM reduced HbA1c, FPG, body weight and SBP, and was well 
      tolerated.
FAU - Kadowaki, Takashi
AU  - Kadowaki T
AD  - Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The 
      University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan.
FAU - Haneda, Masakazu
AU  - Haneda M
FAU - Inagaki, Nobuya
AU  - Inagaki N
FAU - Terauchi, Yasuo
AU  - Terauchi Y
FAU - Taniguchi, Atsushi
AU  - Taniguchi A
FAU - Koiwai, Kazuki
AU  - Koiwai K
FAU - Rattunde, Henning
AU  - Rattunde H
FAU - Woerle, Hans J
AU  - Woerle HJ
FAU - Broedl, Uli C
AU  - Broedl UC
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140624
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - HDC1R2M35U (empagliflozin)
MH  - Aged
MH  - *Benzhydryl Compounds/administration & dosage/adverse effects
MH  - Blood Glucose/analysis
MH  - Blood Pressure/drug effects
MH  - *Diabetes Mellitus, Type 2/blood/drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Monitoring/methods
MH  - Female
MH  - *Glucosides/administration & dosage/adverse effects
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Weight Loss/drug effects
EDAT- 2014/06/25 06:00
MHDA- 2016/03/24 06:00
CRDT- 2014/06/25 06:00
PHST- 2014/05/06 00:00 [received]
PHST- 2014/06/25 06:00 [entrez]
PHST- 2014/06/25 06:00 [pubmed]
PHST- 2016/03/24 06:00 [medline]
AID - 10.1007/s12325-014-0126-8 [doi]
PST - ppublish
SO  - Adv Ther. 2014 Jun;31(6):621-38. doi: 10.1007/s12325-014-0126-8. Epub 2014 Jun 
      24.