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.
Summary Objective To provide scientific evidence supporting the efficacy of forest bathing as a natural therapy by investigating its physiological benefits using biological indicators in outdoor ...settings. Study design Within-group comparisons were used to examine psychological and physiological responses to exposure to real forest and urban environments. Methods Young Japanese male adults participated in a 3-day, 2-night field experiment. Physiological responses as well as self-reported psychological responses to forest and urban environmental stimuli were measured in real settings. The results of each indicator were compared against each environmental stimulus. Results Heart rate variability analysis indicated that the forest environment significantly increased parasympathetic nervous activity and significantly suppressed sympathetic activity of participants compared with the urban environment. Salivary cortisol level and pulse rate decreased markedly in the forest setting compared with the urban setting. In psychological tests, forest bathing significantly increased scores of positive feelings and significantly decreased scores of negative feelings after stimuli compared with the urban stimuli. Conclusion Physiological data from this field experiment provide important scientific evidence on the health benefits of forest bathing. The results support the concept that forest bathing has positive effects on physical and mental health, indicating that it can be effective for health promotion. Despite the small sample size in this study, a very clear tendency towards positive physiological and psychological outcomes in forests was observed.
Abstract The Fukushima accident was a compounding disaster following the strong earthquake and huge tsunami. The direct health effects of radiation were relatively well controlled considering the ...severity of the accident, not only among emergency workers but also residents. Other serious health issues include deaths during evacuation, collapse of the radiation emergency medical system, increased mortality among displaced elderly people and public healthcare issues in Fukushima residents. The Fukushima mental health and lifestyle survey disclosed that the Fukushima accident caused severe psychological distress in the residents from evacuation zones. In addition to psychiatric and mental health problems, there are lifestyle-related problems such as an increase proportion of those overweight, an increased prevalence of hypertension, diabetes mellitus and dyslipidaemia and changes in health-related behaviours among evacuees; all of which may lead to an increased cardiovascular disease risk in the future. The effects of a major nuclear accident on societies are diverse and enduring. The countermeasures should include disaster management, long-term general public health services, mental and psychological care, behavioural and societal support, in addition to efforts to mitigate the health effects attributable to radiation.
This multicentre, open‐label, phase III study investigated the safety and efficacy of the G‐protein‐coupled receptor 40 agonist fasiglifam. Japanese patients with type 2 diabetes and inadequate ...glycaemic control despite diet and/or exercise (n = 282), or despite diet and/or exercise plus one oral antidiabetic agent sulphonylurea (n = 262), rapid‐acting insulin secretagogue (n = 124), α‐glucosidase inhibitor (n = 141), biguanide (n = 136), thiazolidinedione (n = 139) or dipeptidyl peptidase‐4 inhibitor (n = 138) were randomized to treatment with fasiglifam 25 or 50 mg once daily for 52 weeks. The primary endpoints were safety variables. The overall incidence of treatment‐emergent adverse events (TEAEs) was 75.4–85.1% in the 25 mg group and 78.9–89.9% in the 50 mg group; most TEAEs were mild. Hypoglycaemia was negligible with fasiglifam monotherapy and most common with sulphonylurea combination therapy (12.4 and 9.1% for 25 and 50 mg groups, respectively). Abnormal liver‐related laboratory values were uncommon. Glycated haemoglobin levels decreased from week 2 in all groups and were maintained to week 52. Although fasiglifam as monotherapy or in combination regimens was well tolerated during long‐term treatment, global concerns about liver safety led to termination of its development after study completion.
We describe a secure communication scheme that uses the random fluctuation of the natural environment of communication channels. Only the transmitter and the receiver share the communication channel ...characteristics. From reciprocity between a transmitter and a receiver, it is possible for them to share one-time information of their fluctuating channel. This can provide a secret key agreement scheme without key management and key distribution processes. In this paper, we propose a new secret key generation and agreement scheme that uses the fluctuation of channel characteristics with an electronically steerable parasitic array radiator (ESPAR) antenna. This antenna, which has been proposed and prototyped, is a smart antenna designed for consumers. Using the beam-forming technique of the ESPAR antenna, we can increase the fluctuation of the channel characteristics. From experimental results, we conclude that the proposed scheme has the ability to generate secret keys from the received signal strength indicator (RSSI) profile with sufficient independence.
A hollow metallic waveguide-input resonant tunnelling diode three-terminal mixer device based on a photonic-crystal platform for terahertz (THz) communication applications is presented. Coherent ...detection was successfully demonstrated, with an increase in the sensitivity of >30 dB compared with that of direct detection. Error-free communications with a data rate >10 Gbit/s at 0.3 THz using the developed device as a coherent THz receiver are achieved.
This brief characterizes one- and two-port passive networks from the viewpoint of oscillator design. A linear circuit theory derives the spectral spread due to RF noise from active devices. The ...formulation finds a frequency derivative function of logarithmic immittance that plays the key role of dominating the spectrum behavior. This leads to an explicit definition of the Q factor by referring to Leeson's basic oscillator model. The derived definition can provide an effective criterion for circuit topology and parameter optimization in low-noise oscillator design.
Aims/hypothesis Although the associations between obstructive sleep apnoea and type 2 diabetes mellitus have been reported in cross-sectional design studies, findings on the prospective association ...between the two conditions are limited. We examined prospectively the association between nocturnal intermittent hypoxia as a surrogate marker of obstructive sleep apnoea and risk of type 2 diabetes. Methods A total of 4,398 community residents aged 40 to 69 years who had participated in sleep investigation studies between 2001 and 2005 were enrolled. Nocturnal intermittent hypoxia was assessed by pulse-oximetry and defined by the number of oxygen desaturation measurements ≤3% per h, with five to <15 per h corresponding to mild and 15 events or more per h corresponding to moderate-to-severe nocturnal intermittent hypoxia, respectively. The development of type 2 diabetes was defined by: (1) fasting serum glucose ≥7.00 mmol/l (126 mg/dl); (2) non-fasting serum glucose ≥11.1 mmol/l (200 mg/dl); and/or (3) initiation of glucose-lowering medication or insulin therapy. Multivariable model accounted for age, sex, BMI, smoking status, current alcohol intake, community, borderline type 2 diabetes, habitual snoring, excessive daytime sleepiness, sleep duration and (for women) menopausal status. Results By the end of 2007, 92.2% of participants had been followed up (median follow-up duration interquartile range 3.0 2.9-4.0 years) and 210 persons identified as having developed diabetes. The multivariable-adjusted hazard ratio (95% CI) for developing type 2 diabetes was 1.26 (0.91-1.76) among those with mild nocturnal intermittent hypoxia and 1.69 (1.04-2.76) among those with moderate-to-severe nocturnal intermittent hypoxia (p = 0.03 for trend). Conclusions/interpretation Nocturnal intermittent hypoxia was associated with increased risk of developing type 2 diabetes among middle-aged Japanese.
Lifestyle behaviours associated with the incidence of type 2 diabetes mellitus (T2DM) need further clarification using health insurance data.
This is a cohort study.
In 2015, 193,246 participants ...aged 40–74 years attended the specific health checkups and were observed up to 2020 in Fukushima, Japan. Using the principal component analysis, we identified two patterns from ten lifestyle behaviour questions, namely, the “diet–smoking” pattern (including smoking, alcohol drinking, skipping breakfast, eating fast, late dinner, and snacking) and the “physical activity–sleep” pattern (including physical exercise, walking equivalent activity, walking fast, and sufficient sleep). Then, individual pattern scores were calculated; the higher the scores, the healthier the behaviours.
The accumulative incidence rate of T2DM was 630.5 in men and 391.9 in women per 100,000 person-years in an average of 4 years of follow-up. Adjusted for the demographic and cardiometabolic factors at the baseline, the hazard ratio (95% confidence interval) of the highest versus lowest quartile scores of the “diet–smoking” pattern for T2DM risk was 0.82 (0.72, 0.92; P for trend = 0.002) in men and 0.87 (0.76, 1·00; P for trend = 0.034) in women; that of the “physical activity–sleep” pattern was 0.92 (0.82, 1·04; P for trend = 0.0996) in men and 0.92 (0.80, 1·06; P for trend = 0.372) in women. The “physical activity–sleep” pattern showed a significant inverse association in non-overweight men.
Lifestyle behaviour associated with a healthy diet and lack of smoking may significantly lower the risk of T2DM in middle-aged Japanese adults.
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