Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: A randomized, controlled phase 3 trial
Onishi Y.,Institute for Adult Diseases |
Ono Y.,Takagi Hospital |
Rabol R.,Novo Nordisk AS |
Endahl L.,Novo Nordisk AS |
Nakamura S.,Heiwadai Hospital
Diabetes, Obesity and Metabolism | Year: 2013
Aims: This phase 3, 26-week, open-label, treat-to-target trial investigated the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in insulin-naïve Japanese adults with type 2 diabetes. Methods: Subjects were randomized to once-daily injections of IDegAsp (n=147) or insulin glargine (IGlar) (n=149), both ±≤2 oral antidiabetic treatments. IDegAsp was given before the largest meal at the discretion of each subject (and maintained throughout the trial); IGlar was dosed according to label. Both insulins were titrated to a target prebreakfast self-measured plasma glucose of 3.9 to <5.0mmol/l. Results: After 26weeks, mean HbA1c was 7% with IDegAsp and 7.3% with IGlar; superiority of IDegAsp to IGlar was shown (estimated treatment difference, ETD; IDegAsp-IGlar: -0.28% points [-0.46; -0.10]95% CI, p<0.01). At end-of-trial, mean fasting plasma glucose (FPG) was similar for IDegAsp and IGlar (5.7 vs. 5.6mmol/l; ETD IDegAsp-IGlar: 0.15mmol/l [-0.29; 0.60]95% CI, p=NS). IDegAsp was associated with numerically lower rates of overall confirmed (27%) and nocturnal confirmed hypoglycaemia (25%) versus IGlar (estimated rate ratio IDegAsp/IGlar: 0.73 [0.50; 1.08]95% CI, p=NS, and 0.75 [0.34; 1.64]95% CI, p=NS, respectively). Mean daily insulin doses were similar between groups at end-of-trial (both: 0.41U/kg) as were the increases in body weight from baseline (both: 0.7kg). Adverse event profiles were similar between groups. Conclusions: IDegAsp provided superior long-term glycaemic control compared to IGlar, with similar FPG and doses and numerically lower rates of overall and nocturnal hypoglycaemia (p=NS). © 2013 Blackwell Publishing Ltd.
The pharmacokinetics and pharmacodynamics of tolvaptan in patients with liver cirrhosis with insufficient response to conventional diuretics: A multicentre, double-blind, parallel-group, phase III study
Sakaida I.,Yamaguchi University |
Yanase M.,National Center for Global Health and Medicine |
Kobayashi Y.,Hamamatsu University School of Medicine |
Yasutake T.,Takagi Hospital |
And 2 more authors.
Journal of International Medical Research | Year: 2012
OBJECTIVES: This study investigated the pharmacokinetic and pharmaco - dynamic profile of tolvaptan, and verified its efficacy and safety in patients with liver cirrhosis-associated ascites, with insufficient response to conventional diuretic treatment. METHODS: This multicentre, doubleblind, parallel-group study allocated patients with cirrhosis to receive either 3.75 or 7.5 mg/day tolvaptan orally, once daily, for 7 days. Pharmacokinetic, pharmacodynamic and efficacy variables were measured. RESULTS: Tolvaptan was shown to have high plasma concentrations, and prolongedduration of maximum concentration and half life, in these patients with impaired hepatic function. Tolvaptan resulted in dose-dependent decreases in body weight and ascites volume, and increases in urine output. There were no effects on urinary or serum electrolytes. Tolvaptan was well tolerated, with a good safety profile. CONCLUSIONS: Tolvaptan at 3.75 mg/day exerts some effects due to the pharmacokinetic profile in patients with liver cirrhosis. Tolvaptan at 7.5 mg/day is a clinically useful option for treating patients who do not respond well to conventional diuretics. © SAGE Publications Ltd 2012.
PubMed | Juntendo University, Takagi Hospital, Shizuoka Saiseikai General Hospital, Jinnouchi Hospital and 2 more.
Type: | Journal: Diabetology & metabolic syndrome | Year: 2017
In addition to achieving good glycemic control, diabetes care management aims to improve the quality of life (QOL) in patients. Treatment-associated difficulties and side effects frequently cause deterioration in QOL. Liraglutide, a GLP-1 receptor agonist, is a novel injection drug that promotes insulin secretion. It is a user-friendly, once-daily injection with fewer hypoglycemic events. In this study, we aimed to examine the effect of liraglutide therapy on QOL in patients.In total, 304 insulin- and liraglutide-nave patients with type 2 diabetes were enrolled in this observational study; they received liraglutide therapy for 12weeks. The main outcome measure was change in QOL from baseline, which was assessed using diabetes therapy-related QOL (DTR-QOL).At week 12, liraglutide significantly decreased HbA1c levels (8.71.5 vs. 7.51.3, Liraglutide significantly improved glycemic control and reduced the body weight without deteriorating QOL in obese patients with type 2 diabetes.
PubMed | Choseido Watanabe Clinic, International University of Health and Welfare, Takagi Hospital and Kyoto Tachibana University
Type: Journal Article | Journal: Respiratory care | Year: 2016
Advanced air-flow limitation in patients with COPD leads to a reduction in vital capacity, respiratory muscle strength, and exercise capacity. However, its impact on chest and abdominal wall mobility is unknown. This study aimed to ascertain the prevalence of patients with COPD with reduced chest and abdominal wall mobility and to investigate the effect of reduced chest and abdominal wall mobility on pulmonary function, respiratory muscle strength, and exercise capacity.In 51 elderly male subjects with COPD, chest and abdominal wall mobility, FVC, FEVThe percentages of subjects with reduced mobility were 78% for the upper chest, 76% for the lower chest, and 53% for the abdomen. The subjects with reduced mobility had significantly low FVC, FEVThe majority of subjects with COPD had reduced chest and abdominal wall mobility, which was independently associated with FVC. Even though abdominal wall mobility was relatively preserved compared with chest wall mobility, it was also independently associated with 6MWD.
Motoshima S.,Takagi Hospital |
Irie H.,Saga University |
Nakazono T.,Saga Social Insurance Hospital |
Kamura T.,Kurume University |
Kudo S.,Saga University
Journal of Gynecologic Oncology | Year: 2011
Diffusion-weighted imaging (DWI) reflects changes in proton mobility caused by pathological alterations of tissue cellularity, cellular membrane integrity, extracellular space perfusion, and fluid viscosity. Functional imaging is becoming increasingly important in the evaluation of cancer patients because of the limitations of morphologic imaging. DWI is being applied to the detection and characterization of tumors and the evaluation of treatment response in patients with cancer. The advantages of DWI include its cost-effectiveness and brevity of execution, its complete noninvasiveness, its lack of ionizing radiation, and the fact that it does not require injection of contrast material, thus enabling its use in patients with renal dysfunction. In this article, we describe the clinical application of DWI to gynecological disorders and its diagnostic efficacy therein. © 2011. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology.
Ohbuchi Y.,Funabashi Municipal Medical Center |
Suzuki Y.,Funabashi Municipal Medical Center |
Hatakeyama I.,Funabashi Municipal Medical Center |
Nakao Y.,Saga University |
And 3 more authors.
International Journal of Clinical Oncology | Year: 2014
Background: The present study was undertaken to examine the correlation between serum levels of adiponectin isoforms and the risk for endometrial cancer. Methods: This retrospective case-control study included 43 Japanese women with endometrial cancer and 62 Japanese women with no history of cancer. Serum levels of total adiponectin and the respective isoforms were determined by enzyme-linked immunosorbent assay. Multivariate logistic regression analysis was performed on the serum levels of total adiponectin and its isoforms, high molecular weight, middle molecular weight, and low molecular weight adiponectins, after adjustment for confounders (age, body mass index, hypertension, and diabetes mellitus). Results: The distribution of body mass index revealed a statistically significant difference between patients and controls (P = 0.001). A statistically significant difference (P < 0.01) was also found in the incidence of diabetes mellitus between the two groups, although there was no significant difference in the incidence of hypertension. In controls, an inverse correlation was observed between body mass index and serum adiponectin levels. However, in patients, an inverse correlation was found only between body mass index and serum middle molecular weight adiponectin level. After adjustment for confounding variables, the factor found to be most closely associated with endometrial cancer was a lower serum level of middle molecular weight adiponectin (adjusted odds ratio 4.89, 95 % confidence interval value 1.25-19.11, P = 0.022). Conclusion: Low serum level of middle molecular weight adiponectin was the only independent risk factor for endometrial cancer suggesting that the application of adiponectin might prevent or decrease the risk for endometrial cancer. © 2013 Japan Society of Clinical Oncology.
PubMed | Orthopedics Clinic Medical Papas, Takagi Hospital and Keio University
Type: Journal Article | Journal: PM & R : the journal of injury, function, and rehabilitation | Year: 2016
Balance decreases and activities of daily living (ADLs) deteriorate in older people with knee osteoarthritis (KOA); however, little is known about the systems underlying poor balance control and how those impaired systems are related to decreased ADL.To explore which balance systems are particularly impaired and to examine the relationship between physical ADL and balance in older people with KOA.Case-control study.Outpatient clinic.Thirty people with KOA (mean age: 75.4 years) and 30 age-matched healthy adults (mean age: 75.4 years).The Balance Evaluation Systems Test (BESTest), consisting of 6 sections to evaluate theoretically driven balance control systems, was used for balance assessment. BESTest section scores were compared by use of the Wilcoxon rank-sum test. Pain and physical ADL in the KOA group were evaluated with the Japanese edition of the Western Ontario and McMaster Universities Osteoarthritis Index. Spearman correlation coefficients and partial rank correlation coefficients were used to investigate the relationship between physical ADL and the BESTest scores, pain, radiography findings, and body mass index.The BESTest total and section scores.Compared with controls, 5 of 6 BESTest section scores were significantly lower in the KOA group. Physical ADL was significantly correlated with the total BESTest score (r = -0.484, P = .007), pain (r = 0.635, P < .001), Kellgren and Lawrence grade (r = 0.601, P < .001), and body mass index (r = 0.403, P = .027). Partial rank correlation coefficients between physical ADL and the total BESTest score (r = -0.443, P = .021) or section VI-Stability in Gait (r = -0.466, P = .014) were significant after we controlled for other variables.Most balance systems were impaired in older people with KOA, and this impairment was associated independently with decreased physical ADL.
PubMed | Takagi Hospital and Kyushu University
Type: Journal Article | Journal: Cytotechnology | Year: 2016
Many cytological studies have reported that the numbers of binucleated cells were elevated in various tumors. However, binucleated cells are observed in not only malignant tumors but also normal tissues. Thus, the clinical significance of binucleated cells is controversial. Here we attempted to elucidate the characteristics of binucleated HeLa cells using time-lapse microscopy. To examine the frequency, viability, proliferation, and formation mechanism of binucleated cells, we grew HeLa cells on chamber slides and tissue culture dishes in DMEM supplemented with (10, 3, 1 and 0.5% media) and without fetal bovine serum (0% medium). The proliferation was evaluated by the medium improvement examination (cultured for 2 more days in 10% medium after culturing in 0% medium; starvation). In the 0% medium, 150 binucleated cells were formed by cytokinesis failure. There were significantly more binucleated cells in the 0% medium than in the 10, 3, 1 and 0.5% media. About twice the number of binucleated cells underwent mitosis in the improvement examinations than in the serum-free examination. We found here that starvation induced the binucleation of HeLa cells and that some binucleated cells can reproduce. These findings might be helpful for understanding binucleated cells in tumors.