PMID- 25347938
OWN - NLM
STAT- MEDLINE
DCOM- 20151028
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 17
IP  - 2
DP  - 2015 Feb
TI  - A randomized, double-blind, placebo-controlled study on long-term efficacy and 
      safety of ipragliflozin treatment in patients with type 2 diabetes mellitus and 
      renal impairment: results of the long-term ASP1941 safety evaluation in patients 
      with type 2 diabetes with renal impairment (LANTERN) study.
PG  - 152-60
LID - 10.1111/dom.12403 [doi]
AB  - AIMS: To assess the effects of renal impairment (RI) on the efficacy and safety 
      of ipragliflozin in patients with type 2 diabetes mellitus (T2DM). METHODS: A 
      cohort of Japanese patients with T2DM and mild to moderate RI and poor glycaemic 
      control, despite diet/exercise therapy alone or diet/exercise therapy in 
      combination with an oral hypoglycaemic agent (an alpha-glucosidase inhibitor, a 
      sulfonylurea, or pioglitazone), were randomized in a double-blind manner to 50 mg 
      ipragliflozin or placebo once daily for 24 weeks. The patients continued 
      open-label ipragliflozin for a 28-week extension period (total treatment 
      duration: 52 weeks). RESULTS: Ipragliflozin significantly decreased glycated 
      haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels and body weight from 
      baseline to week 24 (last observation carried forward) compared with placebo in 
      all patients with RI. The decreases in HbA1c and FPG levels were statistically 
      significant in patients with mild RI, but not in patients with moderate RI. 
      Ipragliflozin significantly reduced body weight in both RI groups. The 
      improvements in glycaemic control were maintained in the 28-week extension 
      period. Ipragliflozin was associated with no clinically significant safety 
      concerns, and its safety profiles were not influenced by the severity of RI. 
      CONCLUSIONS: Ipragliflozin significantly improved glycaemic control and body 
      weight in patients with T2DM with mild RI, but did not improve glycaemic control 
      in patients with moderate RI. Ipragliflozin is a valid treatment option for 
      patients with mild RI but not those with moderate RI.
CI  - (c) 2014 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Kashiwagi, A
AU  - Kashiwagi A
AD  - Kusatsu General Hospital, Shiga, Japan.
FAU - Takahashi, H
AU  - Takahashi H
FAU - Ishikawa, H
AU  - Ishikawa H
FAU - Yoshida, S
AU  - Yoshida S
FAU - Kazuta, K
AU  - Kazuta K
FAU - Utsuno, A
AU  - Utsuno A
FAU - Ueyama, E
AU  - Ueyama E
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Blood Glucose)
RN  - 0 (Glucosides)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Thiophenes)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 3N2N8OOR7X (ipragliflozin)
SB  - IM
MH  - Blood Glucose/*drug effects/metabolism
MH  - Body Weight
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glucosides/*administration & dosage/*adverse effects
MH  - Glycated Hemoglobin/*drug effects/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/*adverse effects
MH  - Male
MH  - Renal Insufficiency/blood/complications/*metabolism
MH  - Thiophenes/*administration & dosage/*adverse effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - Weight Loss/drug effects
PMC - PMC5024052
OTO - NOTNLM
OT  - SGLT2 inhibitor
EDAT- 2014/10/29 06:00
MHDA- 2015/10/29 06:00
PMCR- 2016/09/15
CRDT- 2014/10/29 06:00
PHST- 2014/06/26 00:00 [received]
PHST- 2014/10/16 00:00 [revised]
PHST- 2014/10/17 00:00 [accepted]
PHST- 2014/10/29 06:00 [entrez]
PHST- 2014/10/29 06:00 [pubmed]
PHST- 2015/10/29 06:00 [medline]
PHST- 2016/09/15 00:00 [pmc-release]
AID - DOM12403 [pii]
AID - 10.1111/dom.12403 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2015 Feb;17(2):152-60. doi: 10.1111/dom.12403.