Treatment Burden on Once-Weekly Omarigliptin Versus Daily Dipeptidyl Peptidase-4 Inhibitors in Patients with Type 2 Diabetes: Randomized Controlled Trial (ONWARD-DPP4 Study).

INTRODUCTION: Preference for quality of life is important in deciding the treatment strategy for patients with type 2 diabetes mellitus. This study aimed to assess the effect of omarigliptin on patients' psychological attitudes and responses compared with daily dipeptidyl peptidase-4 inhibitors (DPP4is) by measuring the burden of pharmacotherapy using the Diabetic Treatment Burden Questionnaire (DTBQ). METHODS: Patients with type 2 diabetes mellitus who were taking daily DPP-4is were enrolled and randomized to a group that switched to omarigliptin or a group that continued daily DPP4is and were monitored for 12 weeks. The primary endpoint was the change in the DTBQ score from baseline to week 12. The secondary endpoints included changes in blood test results, medication preferences and medication adherence. RESULTS: The DTBQ total score significantly decreased from baseline to week 12 in both groups; however, no significant intergroup differences were observed. The DTBQ subscale, implementation and flexibility burden scores significantly decreased in the group that switched to omarigliptin, although no significant intergroup difference in the change was observed. DTBQ scores and medication preferences were associated with improvements in the DTBQ scores. CONCLUSION: Although this study failed to demonstrate the improvement of DTBQ total score by switching from daily DPP4is to omarigliptin compared with continuing the daily DPP4is, the DTBQ subscale score implementation and flexibility burden score were significantly improved only in the group that switched to omarigliptin, suggesting the possibility of switching from daily DPP4is to omarigliptin to decrease the patients' medication burden. TRIAL REGISTRATION: jRCTs031200437.

Quality-of-Life Comparison of Dapagliflozin Versus Dipeptidyl Peptidase 4 Inhibitors in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (J-BOND Study).

INTRODUCTION: No study has compared the effects of sodium-glucose cotransporter 2 inhibitors (SGLT2is) and dipeptidyl peptidase 4 inhibitors (DPP4is) on patients' quality-of-life (QOL). METHODS: We enrolled 253 drug-naïve Japanese patients with type 2 diabetes mellitus (T2DM), randomly assigned them into a dapagliflozin (SGLT2i) group or DPP4i group in approximately 1:1 ratio, and monitored them for 24 weeks. The primary endpoint was the proportion of subjects indicating improvement in the "overall quality of life" domain of SHIELD-WQ-9 at week 24. Secondary endpoints included other domains of SHIELD-WQ-9, DTR-QOL, EQ-5D-5L, medication preference, medication adherence, diet therapy adherence, body weight, body mass index (BMI), abdominal circumference, HbA1c, and frequency of adverse events. RESULTS: The proportion of subjects indicating improvement in the "overall quality of life" domain of SHIELD-WQ-9 at week 24 was higher in the dapagliflozin group (28.4%) than in the DPP4i group (18.6%) (p = 0.08). The proportion of subjects indicating improvement in the "physical health" domain of SHIELD-WQ-9 at week 24 was significantly higher in the dapagliflozin group (42.2%) than in the DPP4i group (23.7%) (p = 0.004). Total scores and domain 1 scores of DTR-QOL showed greater improvement in the dapagliflozin group (14.3 ± 15.6 and 15.5 ± 20.8, respectively) than in the DPP4i group (10.2 ± 15.6 and 10.3 ± 19.5, respectively) (both p = 0.05). EQ-5D-5L scores had significantly improved in the DPP4i group (0.023 ± 0.088) (p = 0.005); the intergroup difference was not significant (p = 0.14). Body weight (p < 0.001), BMI (p < 0.001), and abdominal circumference (p = 0.019) had significantly decreased in the dapagliflozin group compared with the corresponding values in the DPP4i group. CONCLUSION: Dapagliflozin showed a comparable or more favorable benefit on Japanese patients' QOL compared with DPP4is. Dapagliflozin was well tolerated. It significantly reduced body weight, which was significantly correlated with improvement in the patients' QOL. This study demonstrates that dapagliflozin can be used as a first-line drug for T2DM in Japan with a beneficial impact on patients' QOL. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trial Registry (UMIN000030514); Japan Registry of Clinical Trials (jRCTs051180165).

Insulin-like growth factor-1 is inversely associated with liver fibrotic markers in patients with type 2 diabetes mellitus.

AIMS/INTRODUCTION: Insulin-like growth factor-1 (IGF-1) regulates mitochondrial function, oxidative stress, inflammation, stellate cells and insulin sensitivity in the liver, and it might be associated with liver fibrosis from non-alcoholic steatohepatitis. In contrast, type 2 diabetes mellitus is closely associated with the progression from non-alcoholic fatty liver to non-alcoholic steatohepatitis and cirrhosis, so careful evaluation of liver fibrosis is required for patients with type 2 diabetes mellitus. Therefore, we examined the relationship between IGF-1 and liver fibrosis markers in type 2 diabetes patients without obvious alcoholic consumption and determined whether IGF-1 is associated with fibrosis of non-alcoholic fatty liver disease. MATERIALS AND METHODS: We selected 415 patients with type 2 diabetes without obvious alcohol consumption, who were admitted to Uwajima City Hospital between May 2013 and December 2016. We collected and analyzed clinical data to determine correlations between IGF-1 or IGF-1 standard deviation score and fibrosis-4 index or 7S domain of type IV collagen. RESULTS: Multiple linear regression analysis showed that the fibrosis-4 index was inversely correlated with IGF-1 and IGF-1 standard deviation score. Furthermore, the 7S domain of type IV collagen was also inversely correlated with IGF-1 and IGF-1 standard deviation score. CONCLUSIONS: IGF-1 was inversely correlated with liver fibrosis markers in type 2 diabetes mellitus patients without obvious alcoholic consumption. Measuring serum IGF-1 levels might help clinicians to identify type 2 diabetes mellitus patients with advanced non-alcoholic steatohepatitis.

The effectiveness of dapagliflozin for sleep-disordered breathing among Japanese patients with obesity and type 2 diabetes mellitus.

Weight reduction is important in patients with sleep-disordered breathing (SDB). In Japanese patients, slight weight reduction is effective for improving the severity of SDB. However, the effect of weight reduction after administration of sodium glucose co-transporter 2 (SGLT2) inhibitor for SDB remains unclear. The aim of this study was to evaluate the improvement of SDB from baseline after administration of dapagliflozin (5 mg) once daily for 24 weeks among Japanese patients with obesity and type 2 diabetes mellitus. Thirty Japanese patients with type 2 diabetes mellitus and SDB were enrolled in a 24-week, prospective, open-label, single-arm, multicentre trial. SDB was defined as at least five 3% oxygen desaturation index (ODI) events per hour, and moderate to severe SDB was defined as at least 15 ODI events per hour. The primary endpoint was the change in 3% ODI between before dapagliflozin administration and at 24 weeks. The prevalence of moderate to severe SDB was 20% in the present study. After administration of dapagliflozin, fasting glucose, HbA1c, aspartate aminotransferase, total cholesterol, low-density lipoprotein cholesterol, and estimated globular filtration rate decreased significantly. The improvement of 3% ODI was observed in patients with moderate to severe SDB but not mild SDB (from 25.0 ± 3.8 at baseline to 18.5 ± 6.1 at 24 weeks, p = 0.017). In conclusion, dapagliflozin might improve moderate to severe SDB but not mild SDB in Japanese patients with obesity and type 2 diabetes mellitus.

Dapagliflozin improves treatment satisfaction in overweight patients with type 2 diabetes mellitus: a patient reported outcome study (PRO study).

BACKGROUND: The benefits of sodium glucose cotransporters 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus include plasma glucose control, reduction in body weight and blood pressure, and low risk of hypoglycemia, although they may also cause genitourinary infections, polyuria, or volume depletion. It is not clear whether dapagliflozin, an SGLT2 inhibitor, improves treatment satisfaction among patients in a comprehensive way despite the negative side effects. This study assessed the effect of dapagliflozin on glycosylated hemoglobin (HbA1c), body weight, and treatment satisfaction in overweight patients with type 2 diabetes mellitus treated with oral hypoglycemic agents. METHODS: This multicenter, open-label, single-arm observational study included patients with type 2 diabetes mellitus administering dapagliflozin 5 or 10 mg per day for 14 weeks. Changes in treatment satisfaction were evaluated using a new version of the Oral Hypoglycemic Agent-Questionnaire (OHA-Q ver. 2) consisting of 23 items. Correlation between treatment satisfaction and HbA1c levels and body weight were analyzed using the Spearman's rank-correlation coefficient. RESULTS: Of the 221 patients enrolled, 188 completed the study. Mean HbA1c decreased from 7.8 ± 0.7% (62.1 ± 7.5 mmol/mol) to 7.3 ± 0.8% (55.9 ± 8.7 mmol/mol) (change - 0.6 ± 0.7%, P < 0.001) and body weight decreased from 82.5 ± 14.6 to 80.7 ± 14.8 kg (change - 2.3 ± 2.8 kg, P < 0.001). OHA-Q ver. 2 was validated as well, the mean OHA-Q ver. 2 total score increased from 44.3 ± 9.4 to 46.6 ± 9.8 (best score 69, worst score 0; change 2.3 ± 6.6, P < 0.001). The change in body weight significantly correlated with the OHA-Q ver. 2 total score (Spearman's ρ = - 0.17, P = 0.035). The change in HbA1c levels significantly correlated with the satisfaction subscale score (Spearman's ρ = - 0.19, P = 0.011). CONCLUSIONS: Dapagliflozin significantly improved treatment satisfaction among patients with type 2 diabetes mellitus for 14 weeks. Body weight loss significantly correlated with treatment satisfaction.Trial registration UMIN-CTR: UMIN000016304.

Physical activity and prevalence of erectile dysfunction in Japanese patients with type 2 diabetes mellitus: The Dogo Study.

AIMS/INTRODUCTION: To date, there is no evidence regarding the association between physical activity (PA) and erectile dysfunction (ED) among Japanese patients with type 2 diabetes mellitus. We investigated this issue among Japanese patients with type 2 diabetes mellitus. MATERIALS AND METHODS: Study participants were 460 male Japanese patients with type 2 diabetes mellitus. The definitions of exercise habit, walking habit and fast walking were based on a self-administered questionnaire regarding PA behavior. Participants were classified into one of four PA levels based on the number of 'Yes' answers to the three questions in the questionnaire: (i) lowest; (ii) lower; (iii) moderate; and (iv) higher. Severe ED and moderate-to-severe ED were based on Sexual Health Inventory for Men score <8 and <12, respectively. RESULTS: The prevalence of moderate-to-severe ED, severe ED, exercise habit, walking habit, and fast walking was 64.6, 51.1, 36.3, 41.3 and 37.6%, respectively. Walking habit was independently inversely associated with moderate-to-severe ED and severe ED. Exercise habit was independently inversely associated with severe ED, but not moderate-to-severe ED. Higher PA was independently inversely associated with moderate-to-severe ED and severe ED (adjusted odds ratio 0.42, 95% confidence interval 0.21-0.85; and adjusted odds ratio 0.38, 95% CI: 0.19-0.73, respectively). There was a statistically significant inverse exposure-response relationship between the PA level and moderate-to-severe ED and severe ED (P for trend = 0.02 and 0.005), respectively. CONCLUSIONS: PA might be inversely associated with ED in Japanese patients with type 2 diabetes mellitus.

Eating Behaviours and Prevalence of Gastroesophageal Reflux Disease in Japanese Adult Patients With Type 2 Diabetes Mellitus: The Dogo Study.

OBJECTIVES: In the general population, late-night dinner is positively associated with gastroesophageal reflux disease (GERD). No evidence exists regarding the relationship between eating behaviours and GERD in patients with type 2 diabetes mellitus, though the prevalence of GERD in patients with type 2 diabetes is higher than in those without diabetes. We conducted this study to investigate the association between eating behaviours and GERD in Japanese patients with type 2 diabetes. METHODS: The study's subjects were 817 Japanese patients with type 2 diabetes. GERD was defined as being present when a subject had a Quality of Life and Utility Evaluation Survey Technology (QUEST) score of 4 or higher. The assessment of eating behaviour was performed by self-administered questionnaire. Subjects were considered positive for late-night dinner if they answered yes to the question "Do you eat dinner within 2 hours before bedtime at least 3 times per week? RESULTS: The prevalence values of GERD, skipping breakfast, bedtime snacking, late-night dinner and fast eating were 32.0%, 13.7%, 27.1%, 28.8%, and 44.4%, respectively. Late-night dinner was independently positively associated with GERD in patients with type 2 diabetes; the adjusted odds ratio was 1.46 (95% CI 1.03 to 2.05). No relationships were found between skipping breakfast, bedtime snacking or fast eating and GERD. CONCLUSIONS: Late-night dinner may be positively associated with GERD in Japanese patients with type 2 diabetes.

Nocturia and Prevalence of Depressive Symptoms in Japanese Adult Patients With Type 2 Diabetes Mellitus: The Dogo Study.

OBJECTIVES: No studies have investigated the association between nocturia and depressive symptoms in patients with type 2 diabetes mellitus. Because nocturia and depressive symptoms are common in patients with type 2 diabetes, we examined this association in Japanese patients with type 2 diabetes. METHODS: We studied 762 Japanese patients with type 2 diabetes. A self-administered questionnaire was used to collect information about the variables under study. The subjects were divided into 3 groups according to their nocturnal micturition: 1) no nocturia; 2) mild nocturia (1 void per night) and 3) moderate to severe nocturia (2 or more voids per night). Depressive symptoms were defined as being present when a subject had a Self-Rating Depression Scale score higher than 49. RESULTS: The prevalence values of mild nocturia, moderate to severe nocturia and depressive symptoms were 39.5%, 41.9% and 16.8%, respectively. Both mild nocturia and moderate to severe nocturia were independently positively associated with depressive symptoms in all patients; the adjusted ORs were 1.96 (95% CI 1.06 to 3.77) and 2.58 (95% CI 1.38 to 5.04). In female patients, both mild nocturia and moderate to severe nocturia were independently associated with depressive symptoms; the adjusted ORs were 5.26 (95% CI 1.73 to 20.61) and 6.91 (95% CI 2.15 to 28.54), respectively. In male patients, neither mild nocturia nor moderate to severe nocturia was significantly related to depressive symptoms. CONCLUSIONS: In Japanese female patients with type 2 diabetes, nocturia may be positively associated with depressive symptoms.

Dietary intake habits and the prevalence of nocturia in Japanese patients with type 2 diabetes mellitus.

AIMS/INTRODUCTION: No reports have been published on the association between dietary intake habits and nocturia in the diabetes population. We therefore evaluated this issue among Japanese patients with diabetes mellitus. MATERIALS AND METHODS: Study participants in the present study were 785 Japanese patients with type 2 diabetes mellitus. Self-administered questionnaires were used to assess each type of dietary intake habit. Vegetable intake habit was assessed by the following question: "Do you have vegetables or seaweed every day?" We used the following two outcomes: (i) nocturia: ≥2 voids per night; and (ii) severe nocturia: ≥3 voids per night. Adjustment was made for age, sex, body mass index, glycated hemoglobin, hypertension, dyslipidemia, smoking, drinking, exercise habit, stroke, ischemic artery disease, diabetic nephropathy, diabetic neuropathy and diabetic retinopathy. RESULTS: The prevalence of nocturia, severe nocturia, and vegetable intake habit was 39.9%, 14.4% and 67.3%, respectively. After adjusting for confounding factors, vegetable intake habit was independently inversely associated with nocturia and severe nocturia: the adjusted odds ratios were 0.67 (95% confidence interval [CI] 0.48-0.94) and 0.46 (95% CI 0.30-0.71), respectively. Among male patients, vegetable intake habit was independently inversely associated with severe nocturia, but not nocturia: the adjusted OR was 0.51 (95% CI 0.29-0.88). Among female patients, vegetable intake habit was independently inversely associated with nocturia and severe nocturia: the adjusted ORs were 0.44 (95% CI 0.24-0.79) and 0.34 (95% CI 0.15-0.78), respectively. CONCLUSIONS: We found an inverse association between vegetable intake habit and nocturia in Japanese patients with type 2 diabetes mellitus.

Relationship between urine pH and abnormal glucose tolerance in a community-based study.

AIMS/INTRODUCTION: The association between urine pH and abnormal glucose tolerance in men and women is unclear; therefore, we carried out a community-based, cross-sectional study to investigate sex-specific associations between these values, possible indicators of prediabetes and type 2 diabetes. MATERIALS AND METHODS: We enrolled 4,945 Japanese individuals (2,490 men and 2,455 women), who had undergone annual health checkups. To investigate the relationship between low urine pH and abnormal glucose tolerance, participants were divided into three groups based on their fasting plasma glucose levels (<6.11 mmol/L, 6.11-6.99 mmol/L and ≥6.99 mmol/L), and three groups based on their glycated hemoglobin levels (≤44.3 mmol/mol, 44.3-47.5 mmol/mol and ≥47.5 mmol/mol). To examine the effects of urine pH on abnormal glucose tolerance, participants were categorized into five groups based on their urine pH (5.0, 5.5, 6.0, 6.5 and ≥7.0). RESULTS: Multivariate analysis adjusted for age, body mass index, systolic blood pressure, triglycerides, high-density lipoprotein cholesterol, uric acid, creatinine and antidiabetic agent use showed significant associations between low urine pH and both high fasting plasma glucose and high glycated hemoglobin levels (P for trend = 0.0260, 0.0075) in men. Furthermore, after the same adjustments, prevalence rates of abnormal glucose tolerance (≥6.11 mmol/L and ≥6.99 mmol/L), increased significantly as urine pH levels decreased (P for trend = 0.0483, 0.0181) in men. In women, a similar trend was observed without a significant difference. CONCLUSIONS: Low urine pH is significantly associated with abnormal glucose tolerance; therefore, measuring urine pH might prove useful for identifying patients at high risk for diabetes.

B-type natriuretic peptide and renal function in Japanese patients with type 2 diabetes mellitus: The Dogo Study.

Among patients with type 2 diabetes mellitus, the association between B-type natriuretic peptide (BNP) and renal function remains controversial. We therefore investigated this issue among Japanese patients with type 2 diabetes mellitus. This study included 687 Japanese patients with type 2 diabetes mellitus. BNP levels were divided at quartile points on the basis of the distribution. We used four outcomes regarding the renal function: 1) chronic kidney disease (CKD): estimated glomerular filtration rate (eGFR) < 60ml/min/1.72m2, 2) advanced CKD: eGFR < 30ml/min/1.72m2, 3) microalbuminuria: urinary albumin creatinine ratio (UACR) ≥ 30 mg/g creatinine, and 4) macroalbuminuria: UACR ≥ 300 mg/g creatinine. The prevalence values of CKD, advanced CKD, microalbuminuria, and macroalbuminuria were 27.4％, 2.5%, 31.4%, and 9.3%, respectively. Highest BNP (≥ 39.2 ng/ml) was independently positively associated with microalbuminuria and macroalbuminuria (adjusted ORs, 2.61 [95% CI: 1.53-4.49] and 3.45 [95% CI: 1.46-8.72], respectively). High BNP was not associated with advanced CKD or CKD. There was a statistically significant positive exposure-response relationships between the BNP level and advanced CKD, microalbuminuria, and macroalbuminuria (p for trend = 0.047, 0.001, and 0.003, respectively). BNP level may be independently positively associated with advanced CKD, microalbuminuria, and macroalbuminuria but not CKD in Japanese patients with type 2 diabetes mellitus.

Free testosterone concentration is inversely associated with markers of liver fibrosis in men with type 2 diabetes mellitus.

The association between serum testosterone level and liver fibrosis in patients with non-alcoholic fatty liver disease is unclear. To clarify this association, we investigated the relationship between serum free testosterone concentration and markers of liver fibrosis in men with type 2 diabetes mellitus but no obvious features of alcohol consumption. This retrospective observational cross-sectional study enrolled 248 men with type 2 diabetes mellitus. The FIB-4 index was measured as a marker of liver fibrosis, and multiple linear regression analysis was performed to examine its association with serum free testosterone concentration. In addition, the 7S domain of type IV collagen (IV-7S) was examined in 140 of the 248 patients. The mean free testosterone concentration was 10.6 ± 6.8 pg/mL and the means of the FIB-4 index and IV-7S were 1.64 ± 1.19 and 4.02 ± 1.11 ng/mL, respectively. After adjusting for all relevant variables, serum free testosterone concentrations were inversely associated with both the FIB-4 index and IV-7S (ß; -0.28, P < 0.0001, and ß; -0.28, P = 0.002, respectively). Measuring serum free testosterone concentrations in men with type 2 diabetes mellitus may help to predict progression to advanced liver disease. Identifying patients at risk may help to prevent the development of cirrhosis and hepatocellular carcinoma.

Obesity and the prevalence of nocturia in Japanese elderly patients with type 2 diabetes mellitus: The Dogo study.

AIM: Nocturia is common among patients with type 2 diabetes mellitus, but limited evidence regarding the association between body mass index (BMI) and nocturia exists among such patients. The aim of the present study, therefore, was to evaluate the association between BMI and nocturia among Japanese patients with type 2 diabetes mellitus. METHODS: Study participants were 809 Japanese patients with type 2 diabetes mellitus. Study participants were considered to have nocturia if they answered "two or more" to the question: "How many times do you typically wake up to urinate from sleeping at night until waking in the morning?" We used the following two outcomes: (i) moderate nocturia was defined as ≥2 voids per night; and (ii) severe nocturia was defined as ≥3 voids per night. Participants were categorized into four groups according to their BMI: (i) BMI <18.5; (ii) 18.5 ≤ BMI < 25; (iii) 25 ≤ BMI < 30; and (iv) BMI ≥30. Multiple logistical regression analysis for nocturia in relation to BMI was used, with the category of 18.5 ≤ BMI < 25 as the reference. RESULTS: Obesity (BMI ≥30) was independently positively associated with severe nocturia among elderly patients (age ≥65 years) with type 2 diabetes mellitus, but not among young and middle-aged patients: the adjusted OR was 2.96 (95% CI 1.10-7.83). BMI was not associated with moderate nocturia in all patients. CONCLUSIONS: In Japanese elderly patients with type 2 diabetes mellitus, obesity was independently positively associated with severe nocturia. Geriatr Gerontol Int 2017; 17: 2460-2465.

Macrovascular Complications and Prevalence of Urgency Incontinence in Japanese Patients with Type 2 Diabetes Mellitus: The Dogo Study.

Objective Macrovascular diseases and urgency incontinence are common among Japanese patients with type 2 diabetes mellitus. However, little evidence exists regarding the association between stroke and urgency incontinence among patients with type 2 diabetes mellitus. We examined the associations between macrovascular complications and urgency incontinence among Japanese patients with type 2 diabetes mellitus. Methods The study subjects were 818 Japanese patients with type 2 diabetes mellitus. Urgency incontinence was defined as present when a subject answered "once a week or more" to the question: "Within one week, how often do you leak urine because you cannot defer the sudden desire to urinate?" We adjusted our analyses for sex, age, body mass index, duration of type 2 diabetes, current smoking, current drinking, hypertension, dyslipidemia, glycated hemoglobin, diabetic nephropathy, diabetic retinopathy, and diabetic peripheral neuropathy. Results The prevalence of urgency incontinence was 9.2%. Stroke was independently positively associated with urgency incontinence, with an adjusted odds ratio of 2.34 (95% confidence interval: 1.03-4.95). The associations between ischemic heart disease or peripheral artery disease and the prevalence of urgency incontinence were not significant. Conclusion In Japanese patients with type 2 diabetes mellitus, stroke, but not ischemic heart diseases or peripheral artery disease, was independently positively associated with urgency incontinence.

Improvement of quality of life through glycemic control by liraglutide, a GLP-1 analog, in insulin-naive patients with type 2 diabetes mellitus: the PAGE1 study.

BACKGROUND: 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. METHODS: In total, 304 insulin- and liraglutide-naïve patients with type 2 diabetes were enrolled in this observational study; they received liraglutide therapy for 12 weeks. The main outcome measure was change in QOL from baseline, which was assessed using diabetes therapy-related QOL (DTR-QOL). RESULTS: At week 12, liraglutide significantly decreased HbA1c levels (8.7 ± 1.5 vs. 7.5 ± 1.3, p < 0.001) and BMI (27.9 ± 5.3 vs. 27.3 ± 5.2, p < 0.001). According to the QOL scores, although the treatment modality had changed from non-injection to injection therapy, liraglutide improved patient satisfaction with treatment. Significant correlations were found between change in HbA1c level and satisfaction with treatment, as well as between change in body weight and burden on social and daily activities, anxiety and dissatisfaction with treatment, and hypoglycemia. CONCLUSIONS: Liraglutide significantly improved glycemic control and reduced the body weight without deteriorating QOL in obese patients with type 2 diabetes. Trial registration UMIN-CTR: UMIN000007159.

Smoking and prevalence of nocturia in Japanese patients with type 2 diabetes mellitus: a post-hoc analysis of The Dogo Study.

AIMS: No evidence exists regarding the association between smoking status and nocturia among patients with type 2 diabetes mellitus. We evaluated this association among Japanese patients with type 2 diabetes mellitus by post-hoc analysis. METHODS: Study subjects were 817 Japanese patients with type 2 diabetes mellitus. Study subjects were considered to have nocturia if they answered "once or more" to the question: "Within one week, how many times do you typically wake up to urinate from sleeping at night until waking in the morning?" We used the following three outcomes: (1) nocturia was ≥1 voids per night; (2) moderate nocturia was ≥2 voids per night; and (3) severe nocturia was ≥3 voids per night. Adjustments were made for age, sex, body mass index, hypertension, dyslipidemia, stroke, glycated hemoglobin, current drinking, use of anti-hypertensive agent, use of insulin, use of oral anti-hyperglycemic agent, and diabetic retinopathy. RESULTS: The prevalence values of one void per night, two voids per night, and three or more voids per night were 39.5%, 27.1%, and 14.8%, respectively. Current smoking was independently inversely associated with severe nocturia compared with never or former smoking; the adjusted PR was 0.47 (95%CI: 0.25-0.89). Among the 443 patients who had ever smoked, compared with former smoking, current smoking was independently inversely related to severe nocturia; the adjusted PR was 0.44 (95%CI: 0.24-0.82). CONCLUSIONS: In Japanese patients with type 2 diabetes mellitus, current smoking may be independently inversely associated with severe nocturia.

Self-reported sitting time and prevalence of erectile dysfunction in Japanese patients with type 2 diabetes mellitus: The Dogo Study.

AIMS: No evidence exists regarding the association between sitting time and erectile dysfunction (ED) among patients with type 2 diabetes mellitus. The aim of this study was to evaluate the association between self-reported sitting time and ED among patients with type 2 diabetes mellitus. METHODS: Study subjects were 430 male Japanese patients with type 2 diabetes mellitus (mean age, 60.5years). A self-administered questionnaire was used to collect information on the variables under study. The study subjects were asked about time spent sitting during typical 24-hour periods over the past 12months. Subjects were divided into four groups according to self-reported sitting time: 1) <5hours, 2) 5-7hours, 3) 7-9hours, and 4) ≥9hours. ED was defined as present when a subject had a Sexual Health Inventory for Men score <8. Adjustment was made for age, body mass index, duration of type 2 diabetes, current smoking, current drinking, hypertension, coronary artery disease, stroke, glycated hemoglobin, walking habit, and diabetic neuropathy. RESULTS: The prevalence values of moderate to severe ED and severe ED were 36.1% and 49.8%. At least 9hours sitting was independently positively associated with severe ED but not moderate to severe ED; the adjusted OR was 1.84 (95% CI: 1.06-3.33). In the multivariate model, there was a statistically significant inverse exposure-response relationship between the self-reported sitting time and severe ED (p for trend=0.029). CONCLUSIONS: Self-reported sitting time may be positively associated with ED in Japanese patients with type 2 diabetes mellitus.

Alcohol consumption and prevalence of erectile dysfunction in Japanese patients with type 2 diabetes mellitus: Baseline data from the Dogo Study.

Diabetes mellitus and heavy alcohol consumption are both associated with vascular disease, a category that includes erectile dysfunction (ED). However, the association between alcohol consumption and ED among patients with type 2 diabetes mellitus remains unclear. The aim of the present multicenter cross-sectional study was to investigate the relationship between drinking frequency, weekly alcohol consumption, daily alcohol consumption, and ED among Japanese patients with type 2 diabetes mellitus. Study subjects were 340 male Japanese patients with type 2 diabetes mellitus, aged 19-70 years, who had undergone blood tests at our institutions. A self-administered questionnaire was used to collect information on the variables under study. ED was defined as present when a subject had a Sexual Health Inventory for Men score <8. Adjustment was made for age, body mass index, duration of type 2 diabetes mellitus, current smoking, hypertension, dyslipidemia, glycated hemoglobin, stroke, coronary artery disease, diabetic retinopathy, diabetic nephropathy, and diabetic neuropathy. The prevalence of ED was 43.2% (147/340). The frequency of alcohol consumption and weekly alcohol consumption were independently inversely associated with ED (p for trend p = 0.001 and 0.004, respectively). The relationship between daily alcohol consumption and ED was an inverted J-shaped curve: alcohol consumption of less than 60 g, but not 60 g or more, per day was independently related to a lower prevalence of ED (p for quadratic trend = 0.003). In Japanese men with type 2 diabetes mellitus, an inverted J-shaped relationship between daily alcohol consumption and ED was observed, while frequency of alcohol consumption and weekly alcohol consumption were significantly inversely associated with ED.

Age and Prevalence of Esophageal Reflux Disease in Japanese Patients with Type 2 Diabetes Mellitus: The Dogo Study.

BACKGROUND: Only limited epidemiological evidence exists regarding the relationship between age and gastroesophageal reflux disease (GERD) among Japanese patients with type 2 diabetes mellitus. AIM: The purpose of the present study is to investigate this issue among Japanese patients with type 2 diabetes mellitus. METHODS: A multicenter cross-sectional study was conducted in 847 Japanese patients with type 2 diabetes mellitus. Subjects were divided into quartiles according to age: (1) 19 ≤ age < 56, (2) 56 ≤ age < 64, (3) 64 ≤ age < 71, and (4) 71 ≤ age < 89. GERD was defined as present when a subject had a Carlsson-Dent self-administered questionnaire (QUEST) score ≥4. RESULTS: The prevalence of GERD was 31.5 %. Younger age was independently associated with a higher prevalence of GERD: the adjusted odds ratios (95 % confidence intervals) for GERD in relation to age < 56, 56 ≤ age < 64, 64 ≤ age < 71, and ≥71 were 3.73 (2.16-6.53), 1.98 (1.21-3.27), 1.66 (1.05-2.68), and 1.00 (reference), respectively (P for trend = 0.001). Among 201 patients with PPI or histamine H2-receptor antagonist (H2RA), less than 56 years of age was independently positively associated with GERD: the adjusted OR was 5.68 (95 % CI 1.55-22.18) (P for trend = 0.02). CONCLUSIONS: Younger age may be independently positively associated with GERD among Japanese type 2 diabetes mellitus patients, regardless of the use of PPI or H2RA.

Nocturia and prevalence of erectile dysfunction in Japanese patients with type 2 diabetes mellitus: The Dogo Study.

AIMS/INTRODUCTION: Several epidemiological studies have reported a positive association between nocturia and erectile dysfunction (ED). Yet only limited evidence exists regarding the association between nocturia and ED among patients with type 2 diabetes mellitus, although nocturia and ED are common among type 2 diabetes mellitus patients. MATERIAL AND METHODS: Study participants were 332 male Japanese patients with type 2 diabetes mellitus, aged 19-70 years, who had undergone blood tests at our institutions. A self-administered questionnaire was used to collect information on the variables under study. Adjustment was made for age, body mass index, hypertension, stroke, ischemic heart disease, glycated hemoglobin and diabetic neuropathy. ED, moderate to severe ED and severe ED were defined as present when a participant had a Sexual Health Inventory for Men score <22, <12 and <8, respectively. Study participants were considered to have nocturia if they answered 'once or more' to the question: 'Within 1 week, how many times do you typically wake up to urinate from sleeping at night until waking in the morning?' RESULTS: The prevalence of nocturia was 79.8%. Nocturia was independently positively associated with ED and moderate to severe ED: the adjusted odds ratios were 7.86 (95% confidence interval 2.11-33.56) and 2.17 (95% confidence interval 1.16-4.12), respectively. The positive association between nocturia and severe ED fell just short of significance. CONCLUSIONS: In Japanese men with type 2 diabetes mellitus, nocturia might be associated with ED and moderate to severe ED.