Efficacy and safety of fasiglifam (TAK-875), a G protein-coupled receptor 40
agonist, in Japanese patients with type 2 diabetes inadequately controlled by
diet and exercise: a randomized, double-blind, placebo-controlled, phase III
trial
#MMPMID25787200
Kaku K
; Enya K
; Nakaya R
; Ohira T
; Matsuno R
Diabetes Obes Metab
2015[Jul]; 17
(7
): 675-81
PMID25787200
show ga
AIM: To assess the efficacy and safety of fasiglifam 25 and 50?mg in Japanese
patients with type 2 diabetes inadequately controlled by diet and exercise.
METHODS: This phase III, double-blind, placebo-controlled, multicentre study
included 192 patients randomized to once-daily treatment with fasiglifam 25?mg
(n?=?63) or 50?mg (n?=?62) or placebo (n?=?67) for 24?weeks. The primary efficacy
endpoint was the change from baseline in glycated haemoglobin (HbA1c) at week 24.
RESULTS: At week 24, both fasiglifam groups had significantly reduced HbA1c
levels compared with the placebo group (p?0.0001). The least squares mean
change from baseline in HbA1c was 0.16% with placebo, -0.57% with fasiglifam
25?mg and -0.83% with fasiglifam 50?mg. The percentage of patients who achieved
an HbA1c target of <6.9% at week 24 was also significantly higher (p?0.05) for
fasiglifam 25?mg (30.2%) and 50?mg (54.8%) compared with placebo (13.8%).
Fasiglifam significantly reduced fasting plasma glucose levels at all assessment
points, starting from week 2. The incidence and types of treatment-emergent
adverse events in each fasiglifam group were similar to those in the placebo
group, and hypoglycaemia was reported in 1 patient receiving fasiglifam 50?mg.
There were no clinically meaningful changes in body weight in any treatment
group. CONCLUSIONS: Fasiglifam significantly improved glycaemic control and was
well tolerated, with a low risk of hypoglycaemia in Japanese patients with type 2
diabetes inadequately controlled by diet and exercise; however, in a recent
review of data from overall fasiglifam global clinical trials, concerns about
liver safety arose and the clinical development of fasiglifam was terminated
after this trial was completed.
|Aged
[MESH]
|Asian People
[MESH]
|Benzofurans/*therapeutic use
[MESH]
|Blood Glucose/analysis
[MESH]
|Diabetes Mellitus, Type 2/blood/*drug therapy
[MESH]