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Japanese Clinical Practice Guideline for Diabetes 2019

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Fig. 1
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(Cited from Umemura, S., Arima, H., Arima, S. et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) Hypertens Res. 2019 Sep;42(9):1256. https://doi.org/10.1038/s41440-019-0284-9, with the permission of the JSH)

Fig. 7

(Cited from Umemura, S., Arima, H., Arima, S. et al. The Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2019) Hypertens Res. 2019 Sep;42(9):1356. https://doi.org/10.1038/s41440-019-0284-9, with the permission of the JSH)

Fig. 8

(Cited from Haneda, M., Inagaki, N., Suzuki, R. et al. Glycemic targets for elderly patients with diabetes. Diabetol Int 7, 331–333 (2016). https://doi.org/10.1007/s13340-016-0293-8)

References

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6. Insulin therapy

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9. Diabetic nephropathy

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This article is based on the “Japanese Clinical Practice Guideline for Diabetes 2019” (ISBN:978-4-524-24148-4), which was published in Japanese by Nankodo Co., Ltd. (© The Japan Diabetes Society (JDS), 2019) and has been jointly published in Journal of Diabetes Investigation (the official journal of the Asian Association for the Study of Diabetes: https://doi.org/10.1111/jdi.13306) and Diabetology International (the official English journal of JDS).

The articles are identical except for minor stylistic and spelling differences in keeping with each journal’s style. Either citation can be used when citing this article.

Appendices

Appendix ① Diabetes and cancer

1. Report of the Committee on Diabetes and Cancer I/II

In recent years, clear evidence has emerged from multiple meta-analyses of the available data including those from the Japanese population to demonstrate the association between diabetes and cancer risk [1, 2]. In 2010, the American Diabetes Association and the American Cancer Society jointly released their consensus report on the relationship between diabetes and cancer [3]. Experts from the Japan Diabetes Society and the Japanese Cancer Association launched a Joint Committee, published the first report in 2013, which provided its recommendations for physicians and healthcare providers as well as for the general public (including patients) [4]. The Committee published its second report, “Report of the Joint Committee on Diabetes and Cancer II in 2016 [5].

2. Cancer risk in patients with diabetes

To date, a number of studies have reported the association between diabetes and cancer risk [6, 7]. Generally, diabetes (mainly the type 2 variety) is reported to be associated with an increased risk of colonic, hepatic, pancreatic, breast, endometrial, and bladder cancers, as well as a reduced risk of prostate cancer.

Assumed mechanisms of oncogenesis in diabetes include insulin resistance and associated hyperinsulinemia, hyperglycemia and chronic inflammation. However, whether diabetes is a causal risk factor for cancer remains to be elucidated.

3. Glucose-lowering agents and cancer risk

At present, the association between glucose-lowering agents and the cancer risk remains to be fully clarified. Thus, it is thought to be preferable that priority is given to maximizing the benefits of favorable glycemic control with these agents, with due attention given to the warnings contained in their package inserts.

4. Glycemic control and cancer risk in patients with diabetes

The “Report of the Committee on Diabetes and Cancer II” addressed this issue and examined the impact of glycemic control on the subsequent risk of cancer in patients with diabetes [5], demonstrating that there is no high-quality evidence available, at present, to clarify the association between glycemic control and cancer risk in patients with diabetes.

5. Management and prognosis of patients with cancer and diabetes

It is reported that patients with cancer and diabetes are associated with poorer short-term and long-term life prognosis than patients with cancer without diabetes [8, 9]. It is also shown that patients with cancer and diabetes are less likely to receive aggressive cancer therapy than patients with cancer without diabetes [10] and that patients with pancreatic cancer and diabetes whose HbA1c is 9.0% or higher have a lower survival rate than those whose HbA1c is less than 9.0% [11].

Appendix ② Diabetes and bone mineral metabolism

1. Bone fracture risk of patients with diabetes

Bone strength is determined by the bone mineral density and bone quality. The former is determined by the amount of bone mineral in bone tissue, and the latter is determined by various factors including bone composition and structure. Any decrease in bone strength is associated with an increased risk of bone fracture [1]. The relative risk of developing proximal femoral fractures is increased by about 3- to 7-fold in patients with type 1 diabetes [2–5]. These patients are generally characterized by decreased bone mineral density, but the risk of bone fracture is disproportionately high. It is assumed that deteriorated bone quality as well as decreased bone mineral density accounts for decreased bone strength.

The impact of bone quality is more apparent in patients with type 2 diabetes than those with type 1 diabetes. The relative risk of developing proximal femoral fractures is shown to be increased to 1.3- to 2.8-fold in those with type 2 diabetes [2, 3, 6], although they have significantly greater bone mineral density than those with type 1 diabetes [7].

2. Antidiabetic agents and bone metabolism

A meta-analysis of ten randomized controlled trials (RCTs) comparing patients with type 2 diabetes receiving and those not receiving thiazolidinediones (TZDs; e.g., rosiglitazone, pioglitazone) demonstrated that the relative risk of fracture is increased to 1.45-fold among those receiving TZDs [8]. The relative risk is shown to be increased to 2.23-fold among women but not men receiving TZDs [8].

At present, no consensus has been reached about the risk of fracture associated with the use of insulin, DPP-4 inhibitors, GLP-1 receptor agonists, metformin, or SGLT2 inhibitors.

3. Use of osteoporosis agents in patients with diabetes

A post hoc analysis of data from RCTs demonstrated no significantly different increase in lumbar vertebra or femoral neck with the use of alendronate between patients with type 2 diabetes and controls [9].

Appendix ③ Pancreas/islet transplantation

1. Pancreas transplantation

Pancreas transplantation is broadly divided into simultaneous pancreas and kidney transplantation (SPK), pancreas-after-kidney transplantation (PAK), and pancreas transplantation alone (PTA). SPK accounts for > 80% of all pancreas transplants performed in Japan and the rest of the world.

Data from the 361 brain-dead and non-heart beating donor pancreas transplants, performed in Japan as of the end of 2014, demonstrated a 5-year graft survival rate of 94.9%, with the 5-year pancreas and kidney survival rates of 76.0% and 91.4%, respectively.

2. Islet transplantation

Islet transplantation is a form of tissue transplantation that involves transplanting islets isolated from a donor pancreas into the portal vein of a recipient.

Islet transplantation is performed on insulin-depleted patients with diabetes shown to have severe hypoglycemia repeatedly despite receiving specialist diabetes care.

While, unlike pancreas transplantation, islet transplantation may not allow its recipients to remain off insulin therapy for prolonged periods of time, it is expected to reduce the frequency of hypoglycemia and mean glucose values by stabilizing glycemic variations.

Islets transplantation from non-heart-beating donors were conducted 34 times to a total of 18 patients (male/female, 5/13) with the modified Edmonton protocol between 2004 and 2007 in Japan [1].

As in Western studies, HbA1c was improved, and severe hypoglycemia resolved, among those with successful islet engraftment [1].

While the need for multiple transplants and improvement of long-term prognosis were among the challenges with islet transplantation, the University of Minnesota protocol, which consists of induction immunotherapy with antithymocyte globulin (thymoglobulin) or an anti-TNF-α receptor antibody followed by maintenance therapy with a low-dose calcineurin inhibitor (tacrolimus) and an mTOR inhibitor (sirolimus) or an anti-metabolic agent (mycofenolate mofetil), was reported to lead to the secession from insulin therapy in all 8 patients with type 1 diabetes receiving islet transplants from each single donor [2].

In Japan, from 2012 onwards, islet transplantation was resumed as a part of advanced medical care B program in insulin-depleted patients presenting with severe hypoglycemic episodes, employing a similar protocol to that of the University of Minnesota and is currently being implemented as First-class Regenerative Medicine according to the “Act on Securing Safety of Regenerative Medicine”.

Appendix ④ Large-scale clinical trials in Japan

1. J-DOIT1

Between March 2007 and March 2012, the Japan Diabetes Outcome Intervention Trial 1 (J-DOIT1) was conducted to investigate the effectiveness of non-face-to-face, telephone-based intervention in individuals at high risk of diabetes in preventing incident diabetes.

Of the people undergoing health check-ups in the fiscal year 2006, high-risk individuals [i.e., those with impaired fasting glucose (IFG)] aged 20–65 years were identified and allocated to the intervention group (n = 1367) and the self-management group (n = 1240).

After completion of 1-year intervention, the study followed up all subjects for 5.5 years on average by way of annual health check-ups and questionnaires and found no significant difference in the cumulative incidence of diabetes between the intervention and self-management groups but did find a significantly lower incidence (− 41%) among those receiving telephone counselling 10 times per year than among those receiving such counselling 3 or 6 times per year in the intervention group when analyzed at each study site.

2. J-DOIT 2 (Japan Diabetes Outcome Intervention Trial 2)

The “Japan Diabetes Outcome Intervention Trial 2 (J-DOIT 2)” was an interventional study intended to address how to decrease consultation interruptions by patients with type 2 diabetes. The interventional measures implemented in the study included encouraging patients who were being treated by their family physicians to continue treatment/consultation, providing healthcare instructions, and assisting their family physicians in their treatment/consultations.

The results of the study demonstrated that treatment/consultation interruptions decreased by 63%, suggesting that the interventional measures were significantly effective.

3. J-DOIT 3 (the Japan Diabetes Optimal Integrated Treatment study for 3 major risk factors of cardiovascular diseases (J-DOIT 3)

In J-DOIT3, a total of 2542 patients with type 2 diabetes and hypertension/dyslipidemia aged 45–69 years were randomly assigned to receive current guideline-consistent treatment [conventional therapy group; targets, HbA1c < 6.9%, blood pressure 130/80 mmHg, LDL-cholesterol < 120 mg/dL (or < 100 mg/dL in those with a history of cardiovascular disease)] or to receive treatment aimed at more stringent control [intensive therapy group; targets, HbA1c < 6.2%, blood pressure 120/75 mmHg, LDL-cholesterol < 80 mg/dL (or < 70 mg/dL in those with a history of cardiovascular disease)].

At a median follow-up of 8.5 years, the primary endpoints of the study (i.e., all-cause mortality, myocardial infarction, stroke, coronary/cerebral artery revascularization) were reduced by 19% in the intensive therapy group, while this reduction was not significantly different from that in the conventional therapy group (P = 0.094) but were significantly reduced by 24% after adjustment for all pre-specified factors, such as smoking (P = 0.042), compared to that in the conventional therapy group [1].

4. JDCP study

The JDCP study was a large-scale prospective observational study of Japanese patients with type 1 and type 2 diabetes. The study was conducted to identify the risk factors for diabetes-related comorbidities that they develop during follow-up.

The JDCP study enrolled a total of 6338 patients, 40–74 years of age who were being treated at participating sites nationwide between June 2007 and November 2009. The primary endpoints of the study included the onset/progression of nephropathy, retinopathy, neuropathy, macroangiopathy, and periodontal disease.

All events observed in the course of the study are currently being reviewed by the 8 subspecialty working groups involved in the study.

5. J-DREAMS

A large-scale registry needs to be built in an attempt to clarify how patients with diabetes are being currently treated and how diabetic complications may occur as a result, as well as to provide recommendations toward improved diabetes care and healthcare policy. Thus, with these objectives in mind, a large-scale registry has been built since 2015 as a joint project between the Japan Diabetes Society (JDS) and the National Center for Global Health and Medicine, solicitating the participation of JDS-accredited diabetes education facilities.

At the end of 2018, a total of 51 university and other facilities have participated in the project, with the number of patients registered totaling some 54,000, of whom 1900 or more patients have type 1 diabetes.

Conflict of interest

Eiichi Araki received honoraria from AstraZeneca, Daiichi Sankyo, Kowa, Mitsubishi Tanabe Pharma, MSD, Novo Nordisk, Ono Pharmaceutical and Sanofi, also received subsidies or donations from Astellas Pharma, Bayer Yakuhin, Daiichi Sankyo, Eli Lilly Japan, Kowa, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Novartis Pharma, Novo Nordisk, Pfizer Japan, Sanofi, Sumitomo Dainippon Pharma, Taisho Pharmaceutical and Takeda Pharmaceutical, and belongs to endowed departments by MSD, Ono Pharmaceutical and Terumo. Mitsuhiko Noda received subsidies or donations from Astellas Pharma, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly Japan, Mitsubishi Tanabe Pharma, MSD, Novo Nordisk Pharma, Ono Pharmaceutical, Sumitomo Dainippon Pharma, Takeda Pharmaceutical and Teijin Pharma. Hiroshi Noto received honoraria from Eli Lilly Japan and MSD. Haruhiko Osawa received research funding from Daiichi Sankyo, Ono Pharmaceutical, Sysmex, Taisho Toyama Pharmaceutical and Takeda Pharmaceutical. Yukio Tanizawa received honoraria from Astellas Pharma, MSD, Novo Nordisk Pharma, Ono Pharmaceutical and Takeda Pharmaceutical, also received research funding from Seastar, also received subsidies or donations from Astellas Pharma, Daiichi Sankyo, Eli Lilly Japan, Kyowa Kirin, Mitsubishi Tanabe Pharma, MSD, Nippon Boehringer Ingelheim, Sanofi, Sumitomo Dainippon Pharma and Takeda Pharmaceutical. Kazuyuki Tobe received honoraria from Novo Nordisk Pharma, Kowa Pharmaceutical and Astellas Pharma, also received research funding from The Uehara Memorial Foundation and The Naito Foundation, also received subsidies or donations from Mitsubishi Tanabe Pharma, Takeda Pharmaceutical, Daiichi Sankyo, MSD, Asahi Kasei Pharma, Teijin Pharma, Boehringer Ingelheim, Ono Pharmaceutical, Novo Nordisk Pharma, Eli Lilly Japan, Fuji Chemical Industries and Arkray. Narihito Yoshioka received honoraria from Novo Nordisk Pharma and Takeda Pharmaceutical. Atsushi Goto, Tatsuya Kondo, Hideki Origasa, Akihiko Taguchi have nothing to declare.

The Japan Diabetes Society: Organizational Conflict of Interest

Co-sponsored seminar: Abbott Diagnostics Medical, Abbott Japan, Abbott Vascular Japan, Aegerion Pharmaceuticals, Ajinomoto, AR Brown, Arkray, Arkray Global Business, Asahi Kasei Pharma, ASKA Pharmaceutical, Astellas Pharma, AstraZeneca, Bayer Yakuhin, Cosmic Corporation, Covidien Japan, Daiichi Sankyo, Eiken Chemical, Eizai, Eli Lilly Japan, Fujifilm Pharma, Fujifilm Toyama Chemical, Fukuda Colin, Fukuda Denshi, Gilead Sciences, Hakubaku, Healthy Network, Hitachi Chemical Diagnostics Systems, Horiba, InBody Japan, Johnson & Johnson, Kaken Pharmaceutical, Kissei Pharmaceutical, Kotobuki Pharmaceutical, Kowa, Kracie Pharmaceutical, Kyowa Kirin, LifeScan Japan, LSI Medience, Medtronic Japan, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, MSD, Mylan EPD, Nikkiso, Nippon Becton Dickinson, Nippon Boehringer Ingelheim, Nipro, Novartis Pharma, Novo Nordisk Pharma, Ono Pharmaceutical, Otsuka Pharmaceutical, Rizap Group, Roche DC Japan, Sanofi, Santen Pharmaceutical, Sanwa Kagaku Kenkyusho, SRL, Sumitomo Dainippon Pharma, Taisho Pharma, Taisho Pharmaceutical, Takeda Pharmaceutical, Terumo, Unex, Welby

Supporting member: Abbott Japan, Arkray Global Business, Astellas Pharma, AstraZeneca, Bunkodo, Chugai Pharmaceutical, Daiichi Sankyo, EA Pharma, Eizai, Eli Lilly Japan, H+B Life Science, Horiba, Japan Tobacco, Johnson & Johnson, Kaken Pharmaceutical, Kissei Pharmaceutical, Kowa, Kyowa Kirin, LifeScan Japan, Medtronic Japan, Mitsubishi Tanabe Pharma, MSD, Nippon Boehringer Ingelheim, Nipro, Novo Nordisk Pharma, Ono Pharmaceutical, PHC, Roche DC Japan, Sanofi, Sanwa Kagaku Kenkyusho, Sekisui Medical, Shionogi, SRL, Sumitomo Dainippon Pharma, Sysmex, Taisho Pharma, Taisho Pharmaceutical, Takeda Pharmaceutical, Terumo, Tosoh

Research grant: Abbott Japan, Eli Lilly Japan, MSD, Nippon Boehringer Ingelheim, Novo Nordisk Pharma, Sanofi, Takeda Pharmaceutical

Award system: Eli Lilly Japan, Novo Nordisk Pharma, Sanofi

Funding statement: The society received no specific funding for this work.

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The article does not contain any studies with human or animal subjects performed by any of the authors.

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Araki, E., Goto, A., Kondo, T. et al. Japanese Clinical Practice Guideline for Diabetes 2019. Diabetol Int 11, 165–223 (2020). https://doi.org/10.1007/s13340-020-00439-5

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