Satoru Yamada - Academia.edu (original) (raw)

Papers by Satoru Yamada

Diabetology international, Oct 28, 2015

Diabetology International, 2015

Diabetology, 2021

Low-protein diets have been recommended as diet therapy for the management of chronic kidney dise... more Low-protein diets have been recommended as diet therapy for the management of chronic kidney disease; however, its effect on chronic kidney disease has not been scientifically proven. Although several studies have reported significantly more favorable results with low-protein diet than with normal-protein diet, the renal protective effects of low-protein diets are still unclear in diabetic patients with chronic kidney disease. Moreover, some studies have reported that extremely low-protein diets may increase the risk of mortality. Thus, this paper describes the effectiveness and safety of low-protein diets for patients with diabetic kidney disease by reviewing the historical background of different low-protein diets that were critically examined in several studies.

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 2021

Purpose It is theorized that the prevalence of obesity has not decreased owing to poor adherence ... more Purpose It is theorized that the prevalence of obesity has not decreased owing to poor adherence to implemented programs addressing metabolic syndrome, obesity, and diabetes in Japan. Therefore, we intended to evaluate the influence of a moderately low-carbohydrate diet on improving markers of metabolic syndrome among workers in Japan. Patients and Methods Participants with metabolic syndrome or obesity were recruited based on the eligibility criteria for the Specific Health Guidance program and educated on a moderately low-carbohydrate diet between spring 2016 and fall 2018. The participants were then made to report their food intake and body weight once a week for the next 12 weeks and were counselled on maintaining a moderately low-carbohydrate diet. HbA1c levels, lipid profile, body weight, and sleep quality were evaluated. The normality of the data was evaluated using the Skewness/Kurtosis test. Each variable was compared before and after the intervention using the Wilcoxon sig...

International Journal of Environmental Research and Public Health, 2019

Numerous dietary recommendations have been made for the prevention and treatment of diabetes. How... more Numerous dietary recommendations have been made for the prevention and treatment of diabetes. However, many people with diabetes regard healthy dietary behavior as wearisome and have difficulty adhering to nutrition therapy. We, therefore, conducted a questionnaire survey concerning the restaurants that serve meals suitable for people with diabetes. We first aimed to determine the number of restaurants that were aware of the need to create special menus for people with diabetes. Second, we aimed to encourage restaurants’ serving of tasty, healthy food and promote easier social living for people with diabetes. We conducted our questionnaire survey every year from 2008 to 2013 on the availability of special menus for people with diabetes at restaurants listed in Michelin Guide Tokyo. We succeeded in increasing the proportion of restaurants offering special meals for people with diabetes from 6.7% (10 of 150 restaurants) in 2008 to 13.2% (32 of 242 restaurants) in 2013. As a result of ...

The Keio Journal of Medicine, 2017

Currently, the low-energy diet is the only recognized nutrition therapy for type 2 diabetes in Ja... more Currently, the low-energy diet is the only recognized nutrition therapy for type 2 diabetes in Japan. However, in recent decades, many foreign scientific organizations have accepted various nutritional approaches to manage diabetes, such as the low-carbohydrate diet, the Mediterranean diet, diet approaches to stop hypertension (DASH), and the vegetarian diet. Moreover, growing evidence has called into question classical nutritional approaches such as the low-fat diet for the prevention of cardiovascular disease and the low-protein diet for the prevention of diabetic kidney disease. Similarly, the recommended nutrition therapy for diabetes may change in near future. Such changes in nutrition therapy must be dynamic and based on not only scientific evidence but also each patient's narrative.

Internal Medicine, 2007

Aim The effect of rapid-acting insulin secretagogues (glinides) on glycemic control when included... more Aim The effect of rapid-acting insulin secretagogues (glinides) on glycemic control when included with insulin therapy for type 2 diabetes remains uncertain. To examine this, we added glinide once a day to twice daily injections of premixed insulin. Research Design and Methods Seventy-four type 2 diabetic patients, taking twice daily injections of premixed insulin and whose diabetic control was stable, were registered at 6 independent institutions. After a 3month observation period, 60 patients were administered 10 mg mitiglinide or 90 mg nateglinide at lunchtime without changing their insulin regimen. After 12 weeks, administration of glinide was discontinued and observation was continued. HbA1c levels were measured at the start of glinide administration, after 12 weeks of glinide , and at 12 weeks after discontinuation. Results HbA1c improved from 7.72±0.66% to 7.55±0.71% (p <0.01) at Week 12 of glinide administration. Twelve weeks after discontinuation, HbA1c returned to the baseline level (7.72±0.81%). Conclusion This study indicates that the addition of glinide once a day at lunchtime to twice daily injections of premixed insulin is effective for the treatment of type 2 diabetes.

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 2009

Nutrients, 2018

This study aimed to elucidate the effect of an energy restricted and carbohydrate restricted diet... more This study aimed to elucidate the effect of an energy restricted and carbohydrate restricted diet on the management of Japanese diabetes patients. Several databases including MEDLINE, EMBASE, and the Japan Medical s Society were searched for relevant articles published prior to June 2017. The articles identified were systematically reviewed. We identified 286 articles on an energy restricted diet, assessed seven and included two studies in our review. On a carbohydrate restricted diet, 75 articles were extracted, seven articles assessed and three included in the review, of which two were the studies that were selected for the energy restricted diet group, since they compared energy restricted diets with carbohydrate restricted diets. All selected studies were on Japanese patients with type 2 diabetes. No studies for type 1 diabetes were found in our search. Two randomized controlled trials on an energy restricted diet were also included in the three studies for a carbohydrate restri...

Objective Although caloric restriction is a widely used intervention to reduce body weight and in... more Objective Although caloric restriction is a widely used intervention to reduce body weight and insulin re-sistance, many patients are unable to comply with such dietary therapy for long periods. The clinical effec-tiveness of low-carbohydrate diets was recently described in a position statement of Diabetes UK and a sci-entific review conducted by the American Diabetes Association. However, randomised trials of dietary inter-ventions in Japanese patients with type 2 diabetes are scarce. Therefore, the aim of this study was to examine the effects of a non-calorie-restricted, low-carbohydrate diet in Japanese patients unable to adhere to a calorie-restricted diet. Methods The enrolled patients were randomly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet. The patients received consultations every two months from a registered dietician for six months. We compared the effects of the two dietary interventions on glycaemic control and metabolic profiles...

Journal of Diabetes Mellitus, 2013

Background: Several studies have shown that twice-daily injections of premixed insulin analogs (M... more Background: Several studies have shown that twice-daily injections of premixed insulin analogs (MIX) could achieve comparable HbA1c levels to basal-bolus (BB) therapy. However, HbA1c does not necessarily reflect short-term glycemic fluctuations that may contribute to the onset or progression of diabetic complications. Therefore, in this study, we compared MIX and BB therapies in terms of their effects on glycemic variability. Methods: We performed a crosssectional observational study of patients attending our outpatient clinics to compare the effects of two insulin regimens on glycemic variability. We recruited patients treated with MIX or BB with HbA1c < 8.4%. A total of 27 patients (11 treated with BB and 16 treated with MIX) were enrolled and wore a continuous glucose monitor (CGM) for 72 h, while continuing their usual lifestyle and insulin doses. Results: No significant differences in CGM-determined glycemic markers were observed between the two groups. However, the post-lunch duration of glucose levels > 180 mg/dL (t > 180) was significantly shorter with BB therapy (88 ± 76 min) than with MIX therapy (145 ± 54 min; p < 0.05). After classification according to HbA1c levels, markers of glycemic variability were better in patients treated with BB than in those treated with MIX in better control group. Conclusion: These results suggest that BB therapy achieves better glucose profiles than MIX therapy in patients with type 2 diabetes, particularly after lunch.

Journal of diabetes science and technology, Jan 18, 2014

The study presents a comparison of the glucose-lowering effects, glycemic variability, and insuli... more The study presents a comparison of the glucose-lowering effects, glycemic variability, and insulin doses during treatment with insulin degludec or insulin glargine. In this open-label, single-center, 2-way crossover study, 13 Japanese diabetic outpatients in the insulin-dependent state on basal-bolus therapy were assigned to receive either insulin glargine followed by insulin degludec, or insulin degludec followed by insulin glargine. Basal insulin doses were fixed in principle, and patients self-adjusted their bolus insulin doses. Seventy-two-hour continuous glucose monitoring was performed 2 weeks after switching the basal insulin. Mean blood glucose (mg/dL) was not significantly different between insulin degludec and insulin glargine over 48 hours (141.8 ± 35.2 vs 151.8 ± 43.3), at nighttime (125.6 ± 40.0 vs 124.7 ± 50.4), or at daytime (149.3 ± 37.1 vs 163.3 ± 44.5). The standard deviation (mg/dL) was also similar (for 48 hours: 48.9 ± 19.4 vs 50.3 ± 17.3; nighttime: 18.7 ± 14.3...

Diabetes, Jan 7, 2014

Type 2 diabetes (T2D) is a metabolic disease affecting >370 million people worldwide. It is ch... more Type 2 diabetes (T2D) is a metabolic disease affecting >370 million people worldwide. It is characterized by obesity-induced insulin resistance, and growing evidence has indicated that this causative link between obesity and insulin resistance is associated with visceral adipose tissue inflammation. However, using anti-inflammatory drugs to treat insulin resistance and T2D is not a common practice. We recently applied a bioinformatics methodology to open public data, and found that CD44 plays critical role in the development of adipose tissue inflammation and insulin resistance. In this report, we examined the role of CD44 in T2D by administering daily injections of anti-CD44 monoclonal antibody in a high-fat diet (HFD) mouse model. Four weeks of therapy with CD44 mAb suppressed visceral adipose tissue inflammation compared to controls and reduced fasting blood glucose levels, weight gain, liver steatosis, and insulin resistance to levels comparable to or better than the drugs me...

Proceedings of the National Academy of Sciences, 2012

Type 2 diabetes (T2D) is a complex, polygenic disease affecting nearly 300 million people worldwi... more Type 2 diabetes (T2D) is a complex, polygenic disease affecting nearly 300 million people worldwide. T2D is primarily characterized by insulin resistance, and growing evidence has indicated the causative link between adipose tissue inflammation and the development of insulin resistance. Genetic association studies have successfully revealed a number of important genes consistently associated with T2D to date. However, these robust T2D-associated genes do not fully elucidate the mechanisms underlying the development and progression of the disease. Here, we report an alternative approach, gene expression-based genome-wide association study (eGWAS): searching for genes repeatedly implicated in functional microarray experiments (often publicly available). We performed an eGWAS across 130 independent experiments (totally 1,175 T2D case-control microarrays) to find additional genes implicated in the molecular pathogenesis of T2D and identified the immune-cell receptor CD44 as our top cand...

The Journal of Immunology, 2004

The Journal of Clinical Endocrinology & Metabolism, 2003

Internal Medicine, 2009

Although recent studies recommended that insulin should be administered to patients with slowly p... more Although recent studies recommended that insulin should be administered to patients with slowly progressive type 1 diabetes, even those with non-insulin dependent status, patients prefer oral hypoglycemic agents to insulin injections. We report a slowly progressive type 1 diabetic patient whose insulin production was preserved for 4 years (ΣC-peptide from 29.48 ng/mL to 24.58 ng/mL) using pioglitazone despite a high titer of anti-GAD antibody (GADA; 120.7 U/mL). This case suggests that pioglitazone might prevent or delay the loss of insulin secretion and insulin dependency in slowly progressive type 1 diabetic patients.

Internal Medicine, 2007

Aim To evaluate the clinical effects of switching from premixed human insulin to a premixed rapid... more Aim To evaluate the clinical effects of switching from premixed human insulin to a premixed rapid-acting insulin analogue in type 2 diabetic patients. Research Design and Methods Thirty patients, who were treated with a twice-daily injection of premixed human insulin, were enrolled and randomized to (i) 50/50 premixed insulin lispro twice-daily at the same daily dose as premixed human insulin (analogue mix group), or (ii) continued premixed human insulin (control group). The doses of insulin were adjusted every month by registered diabetologists to achieve adequate blood glucose levels. At the beginning of the study, and again 4 months later, HbA1c and blood glucose levels were measured, and the amount of insulin required and BMI were recorded in both groups. Insulin therapyrelated quality of life (ITR-QOL) and the diabetes treatment satisfaction questionnaire (DTSQ) were also assessed in the analogue mix group at the beginning of the study and again 4 months later. Results Although HbA1c levels did not change significantly over the duration of the study in the control group (7.33 ± 0.58 vs 7.29 ± 0.65%), HbA1c did improve significantly in the analogue mix group (7.59 ± 0.44 vs 7.24 ± 0.49%; p<0.05). The dose of insulin required in the analogue mix group did not change significantly (0.37 ± 0.11 vs 0.38 ± 0.14 U/kg/day), but increased in the control group from 0.34 ± 0.15 to 0.37 ± 0.16 U/kg/day (p<0.05). The switch to the premixed insulin analogue did not affect ITR-QOL and DTSQ scores. Conclusions This study showed that switching from premixed human insulin to 50/50 premixed insulin lispro improved blood glucose control without compromising QOL. This finding suggests that a premixed rapid-acting insulin analogue is more effective than human insulin for Japanese type 2 diabetic patients.

Diabetology international, Oct 28, 2015

Diabetology International, 2015

Diabetology, 2021

Low-protein diets have been recommended as diet therapy for the management of chronic kidney dise... more Low-protein diets have been recommended as diet therapy for the management of chronic kidney disease; however, its effect on chronic kidney disease has not been scientifically proven. Although several studies have reported significantly more favorable results with low-protein diet than with normal-protein diet, the renal protective effects of low-protein diets are still unclear in diabetic patients with chronic kidney disease. Moreover, some studies have reported that extremely low-protein diets may increase the risk of mortality. Thus, this paper describes the effectiveness and safety of low-protein diets for patients with diabetic kidney disease by reviewing the historical background of different low-protein diets that were critically examined in several studies.

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 2021

Purpose It is theorized that the prevalence of obesity has not decreased owing to poor adherence ... more Purpose It is theorized that the prevalence of obesity has not decreased owing to poor adherence to implemented programs addressing metabolic syndrome, obesity, and diabetes in Japan. Therefore, we intended to evaluate the influence of a moderately low-carbohydrate diet on improving markers of metabolic syndrome among workers in Japan. Patients and Methods Participants with metabolic syndrome or obesity were recruited based on the eligibility criteria for the Specific Health Guidance program and educated on a moderately low-carbohydrate diet between spring 2016 and fall 2018. The participants were then made to report their food intake and body weight once a week for the next 12 weeks and were counselled on maintaining a moderately low-carbohydrate diet. HbA1c levels, lipid profile, body weight, and sleep quality were evaluated. The normality of the data was evaluated using the Skewness/Kurtosis test. Each variable was compared before and after the intervention using the Wilcoxon sig...

International Journal of Environmental Research and Public Health, 2019

Numerous dietary recommendations have been made for the prevention and treatment of diabetes. How... more Numerous dietary recommendations have been made for the prevention and treatment of diabetes. However, many people with diabetes regard healthy dietary behavior as wearisome and have difficulty adhering to nutrition therapy. We, therefore, conducted a questionnaire survey concerning the restaurants that serve meals suitable for people with diabetes. We first aimed to determine the number of restaurants that were aware of the need to create special menus for people with diabetes. Second, we aimed to encourage restaurants’ serving of tasty, healthy food and promote easier social living for people with diabetes. We conducted our questionnaire survey every year from 2008 to 2013 on the availability of special menus for people with diabetes at restaurants listed in Michelin Guide Tokyo. We succeeded in increasing the proportion of restaurants offering special meals for people with diabetes from 6.7% (10 of 150 restaurants) in 2008 to 13.2% (32 of 242 restaurants) in 2013. As a result of ...

The Keio Journal of Medicine, 2017

Currently, the low-energy diet is the only recognized nutrition therapy for type 2 diabetes in Ja... more Currently, the low-energy diet is the only recognized nutrition therapy for type 2 diabetes in Japan. However, in recent decades, many foreign scientific organizations have accepted various nutritional approaches to manage diabetes, such as the low-carbohydrate diet, the Mediterranean diet, diet approaches to stop hypertension (DASH), and the vegetarian diet. Moreover, growing evidence has called into question classical nutritional approaches such as the low-fat diet for the prevention of cardiovascular disease and the low-protein diet for the prevention of diabetic kidney disease. Similarly, the recommended nutrition therapy for diabetes may change in near future. Such changes in nutrition therapy must be dynamic and based on not only scientific evidence but also each patient's narrative.

Internal Medicine, 2007

Aim The effect of rapid-acting insulin secretagogues (glinides) on glycemic control when included... more Aim The effect of rapid-acting insulin secretagogues (glinides) on glycemic control when included with insulin therapy for type 2 diabetes remains uncertain. To examine this, we added glinide once a day to twice daily injections of premixed insulin. Research Design and Methods Seventy-four type 2 diabetic patients, taking twice daily injections of premixed insulin and whose diabetic control was stable, were registered at 6 independent institutions. After a 3month observation period, 60 patients were administered 10 mg mitiglinide or 90 mg nateglinide at lunchtime without changing their insulin regimen. After 12 weeks, administration of glinide was discontinued and observation was continued. HbA1c levels were measured at the start of glinide administration, after 12 weeks of glinide , and at 12 weeks after discontinuation. Results HbA1c improved from 7.72±0.66% to 7.55±0.71% (p <0.01) at Week 12 of glinide administration. Twelve weeks after discontinuation, HbA1c returned to the baseline level (7.72±0.81%). Conclusion This study indicates that the addition of glinide once a day at lunchtime to twice daily injections of premixed insulin is effective for the treatment of type 2 diabetes.

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 2009

Nutrients, 2018

This study aimed to elucidate the effect of an energy restricted and carbohydrate restricted diet... more This study aimed to elucidate the effect of an energy restricted and carbohydrate restricted diet on the management of Japanese diabetes patients. Several databases including MEDLINE, EMBASE, and the Japan Medical s Society were searched for relevant articles published prior to June 2017. The articles identified were systematically reviewed. We identified 286 articles on an energy restricted diet, assessed seven and included two studies in our review. On a carbohydrate restricted diet, 75 articles were extracted, seven articles assessed and three included in the review, of which two were the studies that were selected for the energy restricted diet group, since they compared energy restricted diets with carbohydrate restricted diets. All selected studies were on Japanese patients with type 2 diabetes. No studies for type 1 diabetes were found in our search. Two randomized controlled trials on an energy restricted diet were also included in the three studies for a carbohydrate restri...

Objective Although caloric restriction is a widely used intervention to reduce body weight and in... more Objective Although caloric restriction is a widely used intervention to reduce body weight and insulin re-sistance, many patients are unable to comply with such dietary therapy for long periods. The clinical effec-tiveness of low-carbohydrate diets was recently described in a position statement of Diabetes UK and a sci-entific review conducted by the American Diabetes Association. However, randomised trials of dietary inter-ventions in Japanese patients with type 2 diabetes are scarce. Therefore, the aim of this study was to examine the effects of a non-calorie-restricted, low-carbohydrate diet in Japanese patients unable to adhere to a calorie-restricted diet. Methods The enrolled patients were randomly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet. The patients received consultations every two months from a registered dietician for six months. We compared the effects of the two dietary interventions on glycaemic control and metabolic profiles...

Journal of Diabetes Mellitus, 2013

Background: Several studies have shown that twice-daily injections of premixed insulin analogs (M... more Background: Several studies have shown that twice-daily injections of premixed insulin analogs (MIX) could achieve comparable HbA1c levels to basal-bolus (BB) therapy. However, HbA1c does not necessarily reflect short-term glycemic fluctuations that may contribute to the onset or progression of diabetic complications. Therefore, in this study, we compared MIX and BB therapies in terms of their effects on glycemic variability. Methods: We performed a crosssectional observational study of patients attending our outpatient clinics to compare the effects of two insulin regimens on glycemic variability. We recruited patients treated with MIX or BB with HbA1c < 8.4%. A total of 27 patients (11 treated with BB and 16 treated with MIX) were enrolled and wore a continuous glucose monitor (CGM) for 72 h, while continuing their usual lifestyle and insulin doses. Results: No significant differences in CGM-determined glycemic markers were observed between the two groups. However, the post-lunch duration of glucose levels > 180 mg/dL (t > 180) was significantly shorter with BB therapy (88 ± 76 min) than with MIX therapy (145 ± 54 min; p < 0.05). After classification according to HbA1c levels, markers of glycemic variability were better in patients treated with BB than in those treated with MIX in better control group. Conclusion: These results suggest that BB therapy achieves better glucose profiles than MIX therapy in patients with type 2 diabetes, particularly after lunch.

Journal of diabetes science and technology, Jan 18, 2014

The study presents a comparison of the glucose-lowering effects, glycemic variability, and insuli... more The study presents a comparison of the glucose-lowering effects, glycemic variability, and insulin doses during treatment with insulin degludec or insulin glargine. In this open-label, single-center, 2-way crossover study, 13 Japanese diabetic outpatients in the insulin-dependent state on basal-bolus therapy were assigned to receive either insulin glargine followed by insulin degludec, or insulin degludec followed by insulin glargine. Basal insulin doses were fixed in principle, and patients self-adjusted their bolus insulin doses. Seventy-two-hour continuous glucose monitoring was performed 2 weeks after switching the basal insulin. Mean blood glucose (mg/dL) was not significantly different between insulin degludec and insulin glargine over 48 hours (141.8 ± 35.2 vs 151.8 ± 43.3), at nighttime (125.6 ± 40.0 vs 124.7 ± 50.4), or at daytime (149.3 ± 37.1 vs 163.3 ± 44.5). The standard deviation (mg/dL) was also similar (for 48 hours: 48.9 ± 19.4 vs 50.3 ± 17.3; nighttime: 18.7 ± 14.3...

Diabetes, Jan 7, 2014

Type 2 diabetes (T2D) is a metabolic disease affecting >370 million people worldwide. It is ch... more Type 2 diabetes (T2D) is a metabolic disease affecting >370 million people worldwide. It is characterized by obesity-induced insulin resistance, and growing evidence has indicated that this causative link between obesity and insulin resistance is associated with visceral adipose tissue inflammation. However, using anti-inflammatory drugs to treat insulin resistance and T2D is not a common practice. We recently applied a bioinformatics methodology to open public data, and found that CD44 plays critical role in the development of adipose tissue inflammation and insulin resistance. In this report, we examined the role of CD44 in T2D by administering daily injections of anti-CD44 monoclonal antibody in a high-fat diet (HFD) mouse model. Four weeks of therapy with CD44 mAb suppressed visceral adipose tissue inflammation compared to controls and reduced fasting blood glucose levels, weight gain, liver steatosis, and insulin resistance to levels comparable to or better than the drugs me...

Proceedings of the National Academy of Sciences, 2012

Type 2 diabetes (T2D) is a complex, polygenic disease affecting nearly 300 million people worldwi... more Type 2 diabetes (T2D) is a complex, polygenic disease affecting nearly 300 million people worldwide. T2D is primarily characterized by insulin resistance, and growing evidence has indicated the causative link between adipose tissue inflammation and the development of insulin resistance. Genetic association studies have successfully revealed a number of important genes consistently associated with T2D to date. However, these robust T2D-associated genes do not fully elucidate the mechanisms underlying the development and progression of the disease. Here, we report an alternative approach, gene expression-based genome-wide association study (eGWAS): searching for genes repeatedly implicated in functional microarray experiments (often publicly available). We performed an eGWAS across 130 independent experiments (totally 1,175 T2D case-control microarrays) to find additional genes implicated in the molecular pathogenesis of T2D and identified the immune-cell receptor CD44 as our top cand...

The Journal of Immunology, 2004

The Journal of Clinical Endocrinology & Metabolism, 2003

Internal Medicine, 2009

Although recent studies recommended that insulin should be administered to patients with slowly p... more Although recent studies recommended that insulin should be administered to patients with slowly progressive type 1 diabetes, even those with non-insulin dependent status, patients prefer oral hypoglycemic agents to insulin injections. We report a slowly progressive type 1 diabetic patient whose insulin production was preserved for 4 years (ΣC-peptide from 29.48 ng/mL to 24.58 ng/mL) using pioglitazone despite a high titer of anti-GAD antibody (GADA; 120.7 U/mL). This case suggests that pioglitazone might prevent or delay the loss of insulin secretion and insulin dependency in slowly progressive type 1 diabetic patients.

Internal Medicine, 2007

Aim To evaluate the clinical effects of switching from premixed human insulin to a premixed rapid... more Aim To evaluate the clinical effects of switching from premixed human insulin to a premixed rapid-acting insulin analogue in type 2 diabetic patients. Research Design and Methods Thirty patients, who were treated with a twice-daily injection of premixed human insulin, were enrolled and randomized to (i) 50/50 premixed insulin lispro twice-daily at the same daily dose as premixed human insulin (analogue mix group), or (ii) continued premixed human insulin (control group). The doses of insulin were adjusted every month by registered diabetologists to achieve adequate blood glucose levels. At the beginning of the study, and again 4 months later, HbA1c and blood glucose levels were measured, and the amount of insulin required and BMI were recorded in both groups. Insulin therapyrelated quality of life (ITR-QOL) and the diabetes treatment satisfaction questionnaire (DTSQ) were also assessed in the analogue mix group at the beginning of the study and again 4 months later. Results Although HbA1c levels did not change significantly over the duration of the study in the control group (7.33 ± 0.58 vs 7.29 ± 0.65%), HbA1c did improve significantly in the analogue mix group (7.59 ± 0.44 vs 7.24 ± 0.49%; p<0.05). The dose of insulin required in the analogue mix group did not change significantly (0.37 ± 0.11 vs 0.38 ± 0.14 U/kg/day), but increased in the control group from 0.34 ± 0.15 to 0.37 ± 0.16 U/kg/day (p<0.05). The switch to the premixed insulin analogue did not affect ITR-QOL and DTSQ scores. Conclusions This study showed that switching from premixed human insulin to 50/50 premixed insulin lispro improved blood glucose control without compromising QOL. This finding suggests that a premixed rapid-acting insulin analogue is more effective than human insulin for Japanese type 2 diabetic patients.