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Use of Fixed Ratio Combinations to Improve Glycemic Control in Individuals with Type 2 Diabetes: Experts' Opinion from the Gulf Region. 使用固定比例组合改善2型糖尿病患者的血糖控制:来自海湾地区的专家意见
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-11 DOI: 10.1007/s13300-025-01824-6
Mohamed Hassanein, Thamer Alessa, Khadija A Hafidh, Lamya Alzubaidi, Mahir Jallo, Fatma Al Slail, Hussein Elbadawi, Rayaz A Malik

Sequential addition of oral glucose-lowering therapies, insulin or incretin-based therapy is often required to attain optimal glycemic control and reduce the risk of diabetes-associated complications. Despite advances in treatment, a large proportion of people with type 2 diabetes fail to achieve optimal glycemic control. Recent guidelines emphasize the need to commence injectable options in individuals unable to attain glycemic targets, despite maximal oral therapy. In individuals already on basal insulin, an improvement in glycemic control requires stepwise addition of prandial insulin, full basal-bolus insulin regimen, or additional injectable incretin-based therapy. However, concerns around weight gain and hypoglycemia often limit addition or increase in insulin to improve glycemic control. Treatment simplification i.e. a decrease in treatment complexity, particularly insulin therapy, seeks to alleviate treatment burden without compromising therapeutic efficacy and safety. However, currently there is a lack of guidance on simplifying treatment, particularly for individuals unable to attain glycemic targets. We now provide evidence-based treatment simplification strategies for people with diabetes in the Gulf Cooperation Council region.

为了达到最佳的血糖控制和降低糖尿病相关并发症的风险,通常需要顺序添加口服降糖治疗、胰岛素或肠促胰岛素治疗。尽管治疗取得了进步,但很大一部分2型糖尿病患者未能达到最佳血糖控制。最近的指南强调,对于无法达到血糖目标的个体,尽管进行了最大限度的口服治疗,仍有必要开始注射治疗。在已经接受基础胰岛素治疗的个体中,血糖控制的改善需要逐步增加膳食胰岛素,完整的基础胰岛素方案,或额外的注射胰岛素治疗。然而,对体重增加和低血糖的担忧往往限制了胰岛素的添加或增加,以改善血糖控制。简化治疗,即降低治疗复杂性,特别是胰岛素治疗,旨在减轻治疗负担,同时不影响治疗疗效和安全性。然而,目前缺乏简化治疗的指导,特别是对于无法达到血糖目标的个体。我们现在为海湾合作委员会地区的糖尿病患者提供循证简化治疗策略。
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引用次数: 0
Temporal Changes in SGLT2 Inhibitor and GLP-1 Receptor Agonist Use in Patients with Chronic Kidney Disease and Type 2 Diabetes, 2012-2023: A US Cohort Study. 2012-2023年慢性肾病和2型糖尿病患者使用SGLT2抑制剂和GLP-1受体激动剂的时间变化:一项美国队列研究
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-09 DOI: 10.1007/s13300-025-01825-5
Catherine B Johannes, Craig I Coleman, Csaba P Kovesdy, Anam M Khan, Ryan Ziemiecki, J Bradley Layton, David Vizcaya, Fangfang Liu, Nikolaus G Oberprieler

Introduction: Type 2 diabetes is a leading cause of chronic kidney disease (CKD). Individuals with both conditions have increased risk of poor cardiorenal outcomes and mortality. The rapidly evolving landscape for CKD-protective therapies in type 2 diabetes currently includes sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA), both of which demonstrate cardiorenal outcome benefits. As part of the FOUNTAIN platform (ClinicalTrials.gov ID: NCT05526157; EUPAS ID: EUPAS48148), this study aimed to better understand changes in patient characteristics and treatment patterns corresponding with updates to clinical guideline recommendations and drug labeling and the emergence of new CKD-protective therapies such as finerenone in the US in 2021-2022.

Methods: An observational real-world data study assessed patient characteristics and drug utilization in separate SGLT2i and GLP-1 RA new-user cohorts of adults with CKD and type 2 diabetes in an earlier (1 January 2012-30 June 2021) and a later (9 July 2021-30 September 2023) period using Optum's de-identified Clinformatics® Data Mart Database (Optum® CDM).

Results: Compared with the earlier period new users, later period new users in both cohorts were older, had more severe CKD, used less intensive type 2 diabetes medication, and had better metabolic control; SGLT2i new users more frequently had no type 2 diabetes therapy before the index date and greater congestive heart failure prevalence; and GLP-1 RA new users had increased SGLT2i use and decreased insulin use.

Conclusions: These findings inform and contextualize future studies assessing cardiorenal outcomes for these and additional treatments, including finerenone, for individuals with CKD and type 2 diabetes.

2型糖尿病是慢性肾脏疾病(CKD)的主要原因。同时患有这两种疾病的人,心肾预后不良和死亡的风险增加。目前,快速发展的2型糖尿病ckd保护疗法包括钠-葡萄糖共转运蛋白2抑制剂(SGLT2i)和胰高血糖素样肽-1受体激动剂(GLP-1 RA),这两种药物都显示出心脏肾脏预后的益处。作为FOUNTAIN平台(ClinicalTrials.gov ID: NCT05526157; EUPAS ID: EUPAS48148)的一部分,该研究旨在更好地了解2021-2022年美国临床指南建议和药物标签更新以及新的ckd保护疗法(如finerenone)的出现所对应的患者特征和治疗模式的变化。方法:一项观察性真实世界数据研究使用Optum的去识别Clinformatics®数据市场数据库(Optum®CDM),评估了早期(2012年1月1日至2021年6月30日)和后期(2021年7月9日至2023年9月30日)患有CKD和2型糖尿病的成人SGLT2i和GLP-1 RA新用户队列的患者特征和药物使用情况。结果:与早期新使用者相比,两个队列的后期新使用者年龄更大,CKD更严重,使用的2型糖尿病强化药物较少,代谢控制更好;SGLT2i新使用者在指标日期之前更频繁地没有接受过2型糖尿病治疗,并且充血性心力衰竭的患病率更高;GLP-1 RA新使用者的SGLT2i使用量增加,胰岛素使用量减少。结论:这些发现为未来的研究提供了信息和背景,以评估CKD和2型糖尿病患者使用这些和其他治疗(包括芬烯酮)的心肾结果。
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引用次数: 0
Protective Role of Serum β-Hydroxybutyrate in Early Diabetic Kidney Disease: A Longitudinal Study. 血清β-羟基丁酸酯在早期糖尿病肾病中的保护作用:一项纵向研究。
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-11-01 DOI: 10.1007/s13300-025-01819-3
So Ra Kim, Minyoung Lee, Yong-Ho Lee, Eun Seok Kang, Bong-Soo Cha, Byung-Wan Lee

Introduction: β-Hydroxybutyrate (βHB), the most stable form of ketone bodies, has exhibited protective effects in metabolic and chronic diseases. This study aimed to assess the association between fasting serum βHB levels, measured at baseline in drug-naïve state, and the risk of proteinuria in patients with newly diagnosed type 2 diabetes.

Methods: In this longitudinal study involving 280 patients, baseline fasting serum βHB levels, urine protein parameters, and metabolic parameters were evaluated. To monitor the development of albuminuria (spot urine albumin-to-creatinine ratio ≥ 30.0 mg/gCr) or proteinuria (spot urine protein-to-creatinine ratio > 0.15 g/gCr), patients with normal baseline levels were followed for a mean of 2.40 ± 1.40 years.

Results: Patients were classified into the highest tertile of baseline serum βHB level group and two other lower tertiles. The highest tertile group (median fasting serum βHB: 0.30 mmol/l) had a significantly lower incidence of proteinuria (6.90% vs. 24.3%, p = 0.028) and nonalbumin proteinuria (6.67% vs. 22.9%, p = 0.031) compared to the lower two tertiles. Higher baseline βHB levels were associated with a reduced risk of proteinuria (hazard ratio 0.313, 95% confidence interval 0.110-0.891), adjusted for confounders.

Conclusion: Higher baseline fasting serum βHB levels are linked to a lower risk of proteinuria in newly diagnosed type 2 diabetes, suggesting its potential as a protective metabolic marker in early diabetic kidney disease.

简介:β-羟基丁酸(βHB)是最稳定的酮体形式,在代谢和慢性疾病中显示出保护作用。本研究旨在评估空腹血清βHB水平(在drug-naïve状态下基线测量)与新诊断的2型糖尿病患者蛋白尿风险之间的关系。方法:在这项涉及280例患者的纵向研究中,评估了基线空腹血清βHB水平、尿蛋白参数和代谢参数。为了监测蛋白尿(尿白蛋白与肌酐比值≥30.0 mg/gCr)或蛋白尿(尿白蛋白与肌酐比值> 0.15 g/gCr)的发展,对基线水平正常的患者进行平均2.40±1.40年的随访。结果:将患者分为血清βHB基线水平最高的组和2个较低的组。与低两组相比,高五分位数组(空腹血清βHB中位数:0.30 mmol/l)的蛋白尿发生率(6.90% vs. 24.3%, p = 0.028)和非白蛋白蛋白尿发生率(6.67% vs. 22.9%, p = 0.031)显著降低。较高的基线βHB水平与蛋白尿风险降低相关(风险比0.313,95%可信区间0.110-0.891),经混杂因素调整。结论:在新诊断的2型糖尿病患者中,较高的基线空腹血清βHB水平与较低的蛋白尿风险相关,提示其可能是早期糖尿病肾病的保护性代谢标志物。
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引用次数: 0
Letter to the Editor regarding "Association Between Diabetes Management Behaviors and State-Level Social Vulnerability: A Cross-sectional Study". 致编辑关于“糖尿病管理行为与国家层面社会脆弱性之间的关系:一项横断面研究”。
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-10-18 DOI: 10.1007/s13300-025-01806-8
Schawanya Kaewpitoon Rattanapitoon, Natnapa Heebkaew Padchasuwan, Nav La, Nathkapach Kaewpitoon Rattanapitoon
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引用次数: 0
Tubeless Insulin Pump Combined with a Cloud-Based Data Management Platform: Real-World Evidence from 14,765 French People with Diabetes. 无管胰岛素泵结合基于云的数据管理平台:来自14,765名法国糖尿病患者的真实世界证据
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-11-01 DOI: 10.1007/s13300-025-01814-8
Nathalie Jeandidier, Arthur Bagel, Alice Bonin, Gabriel Guigand, Bruno Guerci

Introduction: This study aimed to examine glucose metrics and insulin delivery patterns in children, adolescents, and adults with type 1 (T1D) or 2 (T2D) diabetes in France using the tubeless Omnipod DASH® pump with and a continuous glucose monitoring (CGM) sensor connected to myDiabby Healthcare® Data Management Platform (DMP).

Methods: Time-stamped CGM and insulin data were extracted from the DMP on December 6, 2023 for 17,344 users whose first data point from the tubeless pump occurred after January 1, 2020. The study population included users with sufficient pump and CGM data (≥ 90 days of use) and ≥ 15.5% of CGM use days reaching > 70% coverage. Analyses were performed by type of diabetes and age group.

Results: Among 14,757 users included in this analysis, most reported having T1D (93.7%), the median age was 33 years (Q1-Q3, 16-51), and the median duration of pump use was 545 days for people with T1D and 505 days for people with T2D (1.49 and 1.38 years, respectively). People with T1D spent a median of 52.5% (Q1-Q3, 43.4-62.5) of time in range (70-180 mg/dL, TIR) and a TIR ≥ 70% was attained by 12.6% of users. The median time below range (TBR, < 70 mg/dL) was 3.7% (Q1-Q3, 2.1-6.1). For users with T2D, median TIR was 66.9% (Q1-Q3, 54.0-77.8), with 42.8% of users achieving a TIR ≥ 70%. Over 90% of all users consumed less than 60 UI/day.

Conclusion: This robust and scalable analysis of a database of substantial quantity, density, and quality found that tubeless pump users achieved moderate glycemic outcomes overall with favorablesafety outcomes in particular, and used the pump consistently. Such databases could be useful for research and patient care, and further work will show how best to use them.

本研究旨在研究法国儿童、青少年和成人1型(T1D)或2型(T2D)糖尿病患者的血糖指标和胰岛素输送模式,使用无管Omnipod DASH®泵和连接到myDiabby Healthcare®数据管理平台(DMP)的连续血糖监测(CGM)传感器。方法:从DMP中提取2023年12月6日的带时间戳的CGM和胰岛素数据,其中17,344名用户的第一个无管泵数据点发生在2020年1月1日之后。研究人群包括有足够的泵和CGM数据的用户(≥90天的使用),≥15.5%的CGM使用天数达到bbb70 %的覆盖率。按糖尿病类型和年龄组进行分析。结果:在本分析纳入的14,757名用户中,大多数报告患有T1D(93.7%),中位年龄为33岁(Q1-Q3, 16-51岁),T1D患者的中位泵使用时间为545天,T2D患者的中位泵使用时间为505天(分别为1.49年和1.38年)。T1D患者在(70-180 mg/dL, TIR)范围内的时间中位数为52.5% (Q1-Q3, 43.4-62.5), 12.6%的患者TIR≥70%。中位低于范围时间(TBR),结论:对大量、密度和质量的数据库进行了稳健、可扩展的分析,发现无管泵使用者总体上达到了中等的血糖结局,特别是良好的安全性结局,并且持续使用泵。这样的数据库可能对研究和病人护理有用,进一步的工作将表明如何最好地利用它们。
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引用次数: 0
A Response to: Letter to the Editor Regarding Association Between Diabetes Management Behaviors and State-Level Social Vulnerability: A Cross-Sectional Study. 致编辑关于糖尿病管理行为与国家层面社会脆弱性之间关系的一封信:一项横断面研究。
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-10-18 DOI: 10.1007/s13300-025-01807-7
Debra Winberg, Nicolas Marchi, Tiange Tang, Lizheng Shi
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引用次数: 0
Trends in the Management of Patients with Type 2 Diabetes Mellitus by Japanese Practitioners. 日本医师对2型糖尿病患者管理的趋势。
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-10-18 DOI: 10.1007/s13300-025-01805-9
Keiko Arai, Tetsuo Nishikawa, Shohei Yuasa, Koichi Hirao, Hisao Mori

Introduction: In recent years, diabetes management by diabetes specialists has evolved owing to various factors such as the introduction of new glucose-lowering drugs. In Japan, many patients with diabetes mellitus are managed by general practitioners (GPs), with the quality of management provided by these GPs playing a crucial role in preventing diabetes-related complications. Despite this importance, trends in diabetes management by GPs remain unclear. This study aimed to assess changes in diabetes management by GPs, comparing data from two nationwide surveys conducted in 2006 and 2018.

Methods: We compared the characteristics and pharmacotherapy of patients with type 2 diabetes (T2DM) managed by GPs and diabetes specialists in 2006 (14,312 and 1038 patients, respectively) and 2018 (6525 and 1545, respectively). Data on age, sex, glycosylated hemoglobin (HbA1c), body mass index (BMI), treatment modalities, types and number of oral antidiabetic drugs (OADs), types of sulfonylureas (SUs), and dose of SUs were compared between the two surveys.

Results: In 2018, patients with T2DM managed by GPs were older and had higher BMI, while exhibiting improved HbA1c levels compared to those in 2006. Dipeptidyl peptidase 4 inhibitors and biguanides were the most and second most frequently prescribed OADs, respectively, with SUs being less prescribed at lower doses. Combination OAD therapy was also more prevalent in 2018 than in 2006.

Conclusion: The observed trends with GPs were consistent with those observed among diabetes specialists, suggesting that many Japanese GPs are adopting current treatments strategies and may be providing appropriate diabetes management.

近年来,由于各种因素,如新的降糖药物的引入,糖尿病专家的糖尿病管理已经发生了变化。在日本,许多糖尿病患者由全科医生(gp)管理,这些全科医生提供的管理质量在预防糖尿病相关并发症方面起着至关重要的作用。尽管如此,全科医生管理糖尿病的趋势仍不清楚。本研究旨在通过比较2006年和2018年两次全国调查的数据,评估全科医生糖尿病管理的变化。方法:我们比较了2006年(14312例)和2018年(6525例和1545例)由全科医生和糖尿病专家管理的2型糖尿病(T2DM)患者的特征和药物治疗。比较两组患者的年龄、性别、糖化血红蛋白(HbA1c)、体重指数(BMI)、治疗方式、口服降糖药(oad)的种类和数量、磺脲类药物(SUs)的种类和剂量。结果:2018年,全科医生管理的T2DM患者年龄较大,BMI较高,但与2006年相比,HbA1c水平有所改善。二肽基肽酶4抑制剂和双胍类药物分别是最常用和第二常用的oad,在较低剂量下,SUs的使用较少。2018年,OAD联合治疗也比2006年更普遍。结论:全科医生观察到的趋势与糖尿病专家观察到的趋势一致,表明许多日本全科医生正在采用当前的治疗策略,并可能提供适当的糖尿病管理。
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引用次数: 0
Cost-Utility of Real-Time Continuous Glucose Monitoring Versus Self-monitoring of Blood Glucose in People with Insulin-Treated Type 2 Diabetes in Sweden. 瑞典胰岛素治疗的2型糖尿病患者实时连续血糖监测与自我血糖监测的成本-效用
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-11-01 DOI: 10.1007/s13300-025-01811-x
Johan Jendle, Sabrina Ilham, Hamza Alshannaq, Jessica Y Matuoka, Richard F Pollock, Waqas Ahmed, Gregory J Norman

Introduction: The aim of this study was to investigate the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with insulin-treated type 2 diabetes (T2D) in Sweden.

Methods: The CORE Diabetes Model (CDM v10) was used for the analysis. Clinical effectiveness data were obtained from the Steno2Tech trial, an investigator-initiated, 12-month, single center randomized controlled trial based in Denmark. Adverse event rates were sourced from a large-scale observational study based in the USA. Costs were obtained from Swedish and European studies and inflated to 2023 Swedish Krona (SEK). The analysis adopted the perspective of the Swedish payer, and a remaining lifetime horizon was used in the base case. A discount rate of 3% was applied to future costs and outcomes on an annual basis. A commonly cited willingness-to-pay (WTP) threshold of SEK 500,000 was used.

Results: rt-CGM led to a gain in mean incremental survival by 0.082 years (11.529 life years for rt-CGM versus 11.447 life years for SMBG). Total mean incremental costs were SEK 138,448 higher with rt-CGM compared with SMBG (SEK 1,151,049 for rt-CGM versus SEK 1,012,601 for SMBG). However, rt-CGM incurred fewer overall diabetes-related complication costs than SMBG over the remaining lifetime horizon. Rt-CGM also yielded a gain in mean incremental quality-adjusted life years (QALYs) of 0.632 (8.608 QALYs for rt-CGM versus 7.976 QALYs for SMBG). The mean incremental cost-utility ratio (ICUR) for rt-CGM was SEK 219,063 per QALY gained, which showed rt-CGM to be cost-effective when compared with the WTP threshold of SEK 500,000. When various indirect cost estimates were incorporated, rt-CGM was consistently more cost-effective than in the base case analysis.

Conclusions: For individuals living in Sweden with T2D requiring insulin treatment, rt-CGM is a cost-effective management option relative to SMBG.

本研究的目的是调查实时连续血糖监测(rt-CGM)与瑞典胰岛素治疗2型糖尿病(T2D)患者自我血糖监测(SMBG)的成本-效用。方法:采用CORE糖尿病模型(CDM v10)进行分析。临床疗效数据来自Steno2Tech试验,这是一项丹麦研究者发起的为期12个月的单中心随机对照试验。不良事件发生率来源于美国的一项大规模观察性研究。费用从瑞典和欧洲的研究中获得,并膨胀到2023瑞典克朗(SEK)。分析采用瑞典付款人的观点,并在基本情况下使用剩余的生命周期。每年对未来成本和结果采用3%的贴现率。通常引用的支付意愿(WTP)阈值为50万瑞典克朗。结果:rt-CGM导致平均增量生存期增加0.082年(rt-CGM为11.529生命年,SMBG为11.447生命年)。与SMBG相比,rt-CGM的总平均增量成本高出138,448瑞典克朗(rt-CGM为1,151,049瑞典克朗,SMBG为1,012,601瑞典克朗)。然而,在剩余的生命周期内,rt-CGM比SMBG产生更少的糖尿病相关并发症成本。Rt-CGM还获得了0.632的平均增量质量调整生命年(QALYs) (Rt-CGM为8.608 QALYs, SMBG为7.976 QALYs)。rt-CGM的平均增量成本效用比(ICUR)为每QALY获得219,063瑞典克朗,这表明与WTP阈值500,000瑞典克朗相比,rt-CGM具有成本效益。当纳入各种间接成本估算时,rt-CGM始终比基本情况分析更具成本效益。结论:对于生活在瑞典的t2dm患者需要胰岛素治疗,相对于SMBG, rt-CGM是一种经济有效的管理选择。
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引用次数: 0
Response to: Letter to the Editor Regarding 'Profile of Metabolic Dysfunction-Associated Steatotic Liver Disease: Mapping Across Different Indian Populations (MAP Study)'. 回复:致编辑的关于“代谢功能障碍相关脂肪变性肝病的概况:绘制不同印度人群的地图(MAP研究)”的信。
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-10-25 DOI: 10.1007/s13300-025-01810-y
Viswanathan Mohan, Kunal Jhaveri
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引用次数: 0
A Multicenter, Prospective, Observational, and Single-Arm Interventional Study of Mirogabalin in Diabetic Peripheral Neuropathic Pain: Rationale and Design of Dia-NeP. 一项多中心、前瞻性、观察性和单臂的米罗巴林治疗糖尿病周围神经性疼痛的介入研究:Dia-NeP的原理和设计。
IF 2.6 3区 医学 Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-10-24 DOI: 10.1007/s13300-025-01809-5
Hideki Kamiya, Ryo Suzuki, Jun Wada, Takahisa Deguchi, Tatsuhito Himeno, Shuhei Yamamoto, Taiki Toyama, Jiro Nakamura

Background/objectives: The exact prevalence of and recent changes in diabetic polyneuropathy (DPN) and diabetic peripheral neuropathic pain (DPNP) in Japan are unclear. The oral gabapentinoid, mirogabalin besylate (mirogabalin), is effective with a good safety profile for DPNP with moderate-to-severe pain (numerical rating scale [NRS] scores ≥ 4). However, clinical evidence for mild pain (NRS scores ≤ 3) is unclear. The Dia-NeP study aims to examine: (1) the prevalences of DPN and DPNP and background factors in patients with type 2 diabetes mellitus (T2DM); and (2) the efficacy and safety of mirogabalin in patients with DPNP, including those with mild pain.

Methods: The Dia-NeP study is a multicenter, prospective study consisting of two parts, a baseline survey and an interventional study, to be conducted from March 2025 to August 2026 in patients with T2DM in Japan. The baseline survey is the observational study investigating the epidemiology of DPN and DPNP, and the interventional study is an exploratory, single-arm, open-label study of 12-week mirogabalin treatment. Of patients with T2DM enrolled in the baseline survey, those diagnosed with DPNP who have an NRS score for pain ≥ 1 will be included in the interventional study. The target sample size is 1000 to 3000 patients for the baseline survey and 100 for the interventional study.

Planned outcomes: The primary endpoint is the change from baseline in the NRS score at week 12 in the interventional study. The safety endpoint is adverse events. This study will not only show the latest prevalence of DPN and DPNP in Japan, but is also the first study to investigate the efficacy and safety of mirogabalin in patients with DPNP having mild pain, as well as moderate-to-severe pain, and is expected to provide useful evidence for future DPN and DPNP treatment.

Trial registration: Japan Registry of Clinical Trials (jRCTs031240623, registered 20/January/2025, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031240623 ).

背景/目的:日本糖尿病多发神经病变(DPN)和糖尿病周围神经性疼痛(DPNP)的确切患病率和近期变化尚不清楚。口服加巴喷丁类药物,贝磺酸米罗巴林(米罗巴林),对于伴有中度至重度疼痛的DPNP(数值评定量表[NRS]评分≥4)是有效的,并且具有良好的安全性。然而,轻度疼痛(NRS评分≤3)的临床证据尚不清楚。Dia-NeP研究旨在研究:(1)2型糖尿病(T2DM)患者DPN和DPNP的患病率及背景因素;(2)米罗巴林治疗DPNP患者(包括轻度疼痛患者)的疗效和安全性。方法:Dia-NeP研究是一项多中心前瞻性研究,包括基线调查和介入性研究两部分,将于2025年3月至2026年8月在日本T2DM患者中进行。基线调查是调查DPN和DPNP流行病学的观察性研究,介入研究是一项为期12周的米罗巴林治疗的探索性、单臂、开放标签研究。在基线调查的T2DM患者中,诊断为DPNP且疼痛NRS评分≥1的患者将被纳入干预性研究。基线调查的目标样本量为1000 - 3000例,介入研究的目标样本量为100例。计划结局:主要终点是介入研究第12周时NRS评分的基线变化。安全性终点是不良事件。本研究不仅将显示DPN和DPNP在日本的最新流行情况,也是首个研究米罗巴林在DPNP轻度疼痛和中重度疼痛患者中的疗效和安全性的研究,有望为今后DPN和DPNP的治疗提供有用的证据。试验注册:日本临床试验注册中心(jRCTs031240623,于2025年1月20日注册,https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031240623)。
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引用次数: 0
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Diabetes Therapy
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