PMID- 28493502
OWN - NLM
STAT- MEDLINE
DCOM- 20180720
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 19
IP  - 12
DP  - 2017 Dec
TI  - Fasiglifam for glycaemic control in people with type 2 diabetes: A phase III, 
      placebo-controlled study.
PG  - 1714-1721
LID - 10.1111/dom.13004 [doi]
AB  - AIM: To investigate the effect of fasiglifam on glycaemic control in people with 
      type 2 diabetes mellitus (T2DM). METHODS: In total, 421 people with T2DM and 
      glycated haemoglobin (HbA1c) >/=7.0% and </=10.5% who had received only diet and 
      exercise treatment for >/=12 weeks prior to screening were randomized to receive 
      fasiglifam 25 or 50 mg or placebo. The primary efficacy endpoint was change from 
      baseline in HbA1c at week 24. RESULTS: The mean participant age was 53.5 years, 
      mean baseline body mass index 32.3 kg/m(2) , and mean baseline HbA1c level 8.05%. 
      Least squares mean changes in HbA1c from baseline to week 24 were: -0.93% 
      (fasiglifam 50 mg), -0.65% (fasiglifam 25 mg) and -0.17% (placebo). 
      Treatment-emergent adverse events (TEAEs) occurred in 53.3%, 48.2% and 39.9% of 
      participants receiving fasiglifam 25 mg, fasiglifam 50 mg, and placebo, 
      respectively. Three participants in each group experienced a serious adverse 
      event (AE). Nine participants had alanine aminotransferase (ALT) elevations >3x 
      upper limit of normal: 5 (3.6%) in the fasiglifam 25-mg group, 4 (2.8%) in the 
      fasiglifam 50-mg group, and none in the placebo group. CONCLUSIONS: The data 
      indicate that fasiglifam effectively reduced HbA1c from baseline for 24 weeks in 
      participants with T2DM. The incidence of TEAEs was higher in the fasiglifam 
      groups; however, the incidence of serious AEs was low overall and similar between 
      groups. ALT elevations were observed only in the fasiglifam groups, which 
      contributed to the decision to terminate the fasiglifam programme after 
      completion of the present study.
CI  - (c) 2017 John Wiley & Sons Ltd.
FAU - Marcinak, John
AU  - Marcinak J
AD  - Takeda Development Center Americas, Inc., Deerfield, Illinois.
FAU - Cao, Charles
AU  - Cao C
AD  - Takeda Development Center Americas, Inc., Deerfield, Illinois.
FAU - Lee, Douglas
AU  - Lee D
AD  - Takeda Development Centre Europe, Ltd., London, UK.
FAU - Ye, Zhan
AU  - Ye Z
AD  - Takeda Development Center Americas, Inc., Deerfield, Illinois.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170711
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Benzofurans)
RN  - 0 (FFAR1 protein, human)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Receptors, G-Protein-Coupled)
RN  - 0 (Sulfones)
RN  - 0 (TAK-875)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Benzofurans/administration & dosage/*adverse effects/therapeutic use
MH  - Body Mass Index
MH  - Chemical and Drug Induced Liver Injury/etiology/physiopathology
MH  - Combined Modality Therapy/adverse effects
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy/metabolism/physiopathology
MH  - Diet, Diabetic
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Exercise
MH  - Female
MH  - Follow-Up Studies
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hyperglycemia/*prevention & control
MH  - Hypoglycemia/chemically induced/*prevention & control
MH  - Hypoglycemic Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Liver/drug effects/physiopathology
MH  - Lost to Follow-Up
MH  - Male
MH  - Middle Aged
MH  - Obesity/complications
MH  - Patient Dropouts
MH  - Receptors, G-Protein-Coupled/*agonists/metabolism
MH  - Sulfones/administration & dosage/*adverse effects/therapeutic use
OTO - NOTNLM
OT  - antidiabetic drug
OT  - glycaemic control
OT  - phase III study
OT  - type 2 diabetes
EDAT- 2017/05/12 06:00
MHDA- 2018/07/22 06:00
CRDT- 2017/05/12 06:00
PHST- 2017/02/21 00:00 [received]
PHST- 2017/05/03 00:00 [revised]
PHST- 2017/05/07 00:00 [accepted]
PHST- 2017/05/12 06:00 [pubmed]
PHST- 2018/07/22 06:00 [medline]
PHST- 2017/05/12 06:00 [entrez]
AID - 10.1111/dom.13004 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2017 Dec;19(12):1714-1721. doi: 10.1111/dom.13004. Epub 2017 
      Jul 11.