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Maeda H.,The Study Group of the Diabetes Committee | Kubota A.,The Study Group of the Diabetes Committee | Tanaka Y.,St. Marianna University School of Medicine | Terauchi Y.,Yokohama City University | Matsuba I.,The Study Group of the Diabetes Committee
Diabetes Research and Clinical Practice | Year: 2012

We evaluated the efficacy and safety of sitagliptin after 3 months' treatment in Japanese type 2 diabetic patients and examined changes in clinical factors. Baseline HbA1c, PPG, BMI, and duration of diabetes may be predictors of HbA1c reduction when using sitagliptin in Japanese type 2 diabetic patients. © 2011 Elsevier Ireland Ltd. Source


Matsuba I.,The Study Group of the Diabetes Committee | Sawa T.,Kawasaki Saiwai Hospital | Kawata T.,The Study Group of the Diabetes Committee | Kanamori A.,The Study Group of the Diabetes Committee | And 15 more authors.
Diabetes Therapy | Year: 2016

Introduction: Guidelines recommend insulin progression for patients with type 2 diabetes (T2D) with inadequate glycemic control. The Multinational Observational Study Assessing Insulin use (MOSAIc [ClinicalTrials.gov identifier, NCT01400971]) study is a 2-year observational study, investigating factors that influence insulin progression in T2D patients. In this first of two reports, we describe baseline clinical and psychosocial characteristics of Chinese, Japanese, and South Korean patients who participated in MOSAIc. Insulin treatment, factors affecting progression, and outcomes will be reported separately. Methods: Patients with T2D using insulin for ≥3 months were eligible. Baseline demographic, clinical, and psychosocial data were collected from patients. Quality of life instruments, including the Diabetes Distress Scale (DDS), were used to assess patient’s concerns about disease management, support, and emotional burden. The association between the DDS and the selected covariates was also assessed. Results: A total of 373 patients in China, 157 in Japan, and 141 in South Korea were enrolled from July 2011 to July 2013. Mean ± standard deviation duration (years) of T2D differed across countries (China 11.4 ± 7.5; Japan 13.8 ± 8.7; South Korea 15.7 ± 8.8; P < 0.0001). Japanese patients used more noninsulin anti-hyperglycemic agents than did Chinese or South Korean patients (P < 0.0001). Exclusive use of basal insulin was most common in Japan and South Korea compared with China, whereas approximately 66.8% of Chinese patients used mixed insulin. Covariates associated with the DDS were younger age [P = 0.044 (Japan)], higher incidence of monthly hypoglycemia [P = 0.036 [China]; P = 0.021 (South Korea)], and male gender [P = 0.037 (South Korea)]. Conclusions: There were significant differences amongst East Asian patients with T2D treated with insulin, including in quality of life scores. Results from the MOSAIc longitudinal analyses will further investigate trends of insulin intensification and barriers to insulin progression. Funding: Eli Lilly and Company. © 2016, The Author(s). Source


Maeda H.,The Study Group of the Diabetes Committee | Kubota A.,The Study Group of the Diabetes Committee | Kanamori A.,The Study Group of the Diabetes Committee | Tanaka Y.,St. Marianna University School of Medicine | And 2 more authors.
Diabetes Research and Clinical Practice | Year: 2015

We found a slight elevation of serum creatinine in the subjects treated with sitagliptin for 2 years and a correlation between creatinine elevation and HbA1c reduction. These results suggest that creatinine elevation is associated with activation of incretin, most possibly with up-regulation of diuretic activity of GLP-1. © 2015 Elsevier Ireland Ltd. Source


Kawata T.,The Study Group of the Diabetes Committee | Kawata T.,St. Marianna University School of Medicine | Kanamori A.,The Study Group of the Diabetes Committee | Kubota A.,The Study Group of the Diabetes Committee | And 20 more authors.
Diabetology International | Year: 2014

Aims: Our goal was to evaluate liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in monotherapy and combination therapy for Japanese type 2 diabetes patients. Materials and methods: Patients with type 2 diabetes (111 men, 83 women; mean age 57.6 ± 12.6 years) were treated with liraglutide and divided into liraglutide monotherapy (n = 147 patients, group A) and liraglutide-sulfonylurea (SU) combination therapy (n = 47, group B) groups. Changes in clinical parameters after liraglutide administration were evaluated. Results: In both groups, significant decreases in glycosylated hemoglobin (HbA1c) were seen after 12 (group A, 7.01 ± 1.38 vs. 7.72 ± 1.57 %, p < 0.01; group b, 7.83 ± 1.19 vs. 8.44 ± 1.47 %, p < 0.01) and 24 weeks (group A, 7.21 ± 1.45 vs. 7.72 ± 1.57 %, p < 0.01; group B, 7.79 ± 1.22 vs. 8.44 ± 1.47 %, p < 0.01). In group A, body weight decreased significantly from before administration (74.5 ± 19.2 kg) to 12 (73.0 ± 17.8 kg) and 24 (72.8 ± 17.6 kg) (p < 0.01) weeks. In group B, body weight decreased significantly from before administration (71.4 ± 17.4 kg) to 12 weeks (70.9 ± 17.9 kg; p < 0.01). Low-density lipoprotein (LDL) cholesterol decreased significantly in group A from before administration (112.6 ± 34.2 mg/dl) to 12 (107.7 ± 35.0 mg/dl; p < 0.005) and 24 (106.3 ± 26.8 mg/dl; p < 0.05) weeks. In group B, LDL cholesterol decreased significantly from before administration (112.1 ± 24.7 mg/dl) to 12 weeks (99.7 ± 24.7 mg/dl; p < 0.05) only. In both groups, no significant differences in systolic and diastolic blood pressures were observed at 12 and 24 weeks compared with before administration. Adverse events after starting liraglutide occurred in 45 patients (23.2 %), 23 (11.9 %) discontinued treatment. Conclusions: Once-daily liraglutide was well tolerated as monotherapy or combination therapy with SU, demonstrating superior glycemic control with a low rate of hypoglycemia and weight loss. © 2013 The Japan Diabetes Society. Source


Kubota A.,The Study Group of the Diabetes Committee | Maeda H.,The Study Group of the Diabetes Committee | Kanamori A.,The Study Group of the Diabetes Committee | Matoba K.,The Study Group of the Diabetes Committee | And 26 more authors.
Journal of Diabetes Investigation | Year: 2012

Aims/Introduction: To determine the efficacy and safety of sitagliptin monotherapy and combination therapy in Japanese type2 diabetes patients after 3months' therapy. Materials and Methods: A retrospective, observational study of 741 type2 diabetes patients was carried out; 110 received sitagliptin monotherapy, and 631 received combination therapy with sitagliptin when other oral medications were insufficient. The primary outcome measure was glycated hemoglobin (HbA1c) measured at 0, 4 and 12weeks of sitagliptin therapy. Results: In the monotherapy and combination therapy groups, HbA1c decreased significantly after 12weeks. Target HbA1c (<7%) was achieved in 39.1% overall. On logistic regression analysis, baseline HbA1c was the strongest contributing factor for achieving target HbA1c; baseline body mass index and duration of diabetes were also significant factors. A total of 82 patients (11%) were unresponsive to sitagliptin. These patients' baseline body mass index was significantly higher and their baseline HbA1c was significantly lower than those of patients who responded to sitagliptin. The most commonly co-administered drugs were sulfonylureas (508 patients). In these patients, the dose of sulfonylurea decreased with time. In 66 patients whose sulfonylurea dosage was reduced when sitagliptin was started, HbA1c and bodyweight decreased significantly after 12weeks. A total of 24 patients receiving sulfonylureas had mild hypoglycemia, but none discontinued sitagliptin. Conclusions: Sitagliptin was effective and safe as both monotherapy and combination therapy in Japanese type2 diabetes patients. When sulfonylureas were ineffective, sitagliptin improved glycemic control. In patients whose sulfonylurea dose was reduced at the start of sitagliptin, blood glucose improved and bodyweight decreased after 12weeks. © 2012 Asian Association for the Study of Diabetes and Wiley Publishing Asia Pty Ltd. Source

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