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AbstractObjectiveMethodsResultsConclusionsTo compare the efficacy and safety of insulin degludec biosimilar B01411 (HS-IDeg) with originator insulin degludec-Tresiba (NN-IDeg) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on oral antidiabetic drugs (OADs) for at least 3 months.This multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study enrolled 362 participants with T2DM. Participants were stratified according to whether the insulin secretagogue (sulfonylurea or glinide) had been used before the screening and then randomized 1:1 to receive once-daily subcutaneous injections of HS-IDeg (n = 180) or NN-IDeg (n = 182) for 18 weeks. The primary endpoint was the change from baseline in glycated hemoglobin (HbA1c) to week 18.At week 18, the least squares (LS) mean change in HbA1c from baseline was -1.34% (95% CI -1.47 to -1.21) and -1.25% (95% CI -1.38 to -1.12) with HS-IDeg and NN-IDeg, respectively. The LS mean difference (HS-IDeg minus NN-IDeg) in HbA1c at week 18 was -0.09% (95% CI -0.28 to 0.10), demonstrating non-inferiority of HS-IDeg to NN-IDeg. Participants achieving HbA1c <7.0% at week 18 was 34.5% and 29.5% with HS-IDeg and NN-IDeg, respectively. Mean decreases in fasting plasma glucose and standard deviation of blood glucose were similar between both groups. Safety and tolerability, including hypoglycemia, adverse events, and weight change were similar between both groups. No severe hypoglycemia and no death occurred in the study.HS-IDeg and NN-IDeg demonstrated similar efficacy and safety over 18 weeks of treatment in Chinese patients with T2DM who had inadequate responses to OADs for at least 3 months. [ABSTRACT FROM AUTHOR]

This document is a summary of a study on the efficacy and safety of ISIS 449884 injection as a monotherapy for patients with type 2 diabetes. The study found that the use of ISIS 449884 resulted in a significant improvement in HbA1c levels compared to a placebo group. The treatment was well-tolerated with no serious adverse events reported. However, there were some limitations to the study, including a small sample size and a lack of data on hepatic lipid values and hepatic fat content. Overall, the study suggests that ISIS 449884 may be an effective and safe treatment option for patients with type 2 diabetes. [Extracted from the article]

Aims: To evaluate the prevalence of vitamin B12 deficiency in Chinese patients with type 2 diabetes mellitus receiving metformin treatment and to investigate the effects of metformin daily dose and treatment duration on the prevalence of vitamin B12 deficiency and peripheral neuropathy (PN). Materials and Methods: In this multicenter cross‐sectional study, 1027 Chinese patients who had been taking ≥1000 mg/day metformin for ≥1 year were enrolled using proportionate stratified random sampling based on daily dose and treatment duration. Primary measures included the prevalence of vitamin B12 deficiency (<148 pmol/L), borderline B12 deficiency (148 pmol/L‐211 pmol/L), and PN. Results: The prevalence of vitamin B12 deficiency, borderline deficiency, and PN were 2.15%, 13.66%, and 11.59%, respectively. Patients receiving ≥1500 mg/day metformin had significantly higher prevalence of borderline vitamin B12 deficiency (16.76% vs. 9.91%, p =.0015) and serum B12 ≤221 pmol/L (19.25% vs. 11.64%, p <.001) than patients receiving <1500 mg/day metformin. No difference was found in prevalence of borderline vitamin B12 deficiency (12.58% vs. 15.49%, p =.1902) and serum B12 ≤221 pmol/L (14.91% vs. 17.32%, p =.3055) between patients receiving metformin for ≥3 and <3 years. Patients with vitamin B12 deficiency had numerically higher PN prevalence (18.18% vs. 11.27%, p =.3192) than patients without it. Multiple logistic analyses revealed that HbA1c and metformin daily dose were associated with the prevalence of borderline B12 deficiency and B12 ≤221 pmol/L. Conclusions: High daily dosage (≥1500 mg/day) played an important role in metformin‐associated vitamin B12 deficiency while not contributing to the risk of PN. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the efficacy and safety of janagliflozin in Chinese patients with type 2 diabetes (T2D) inadequately controlled with metformin monotherapy. Materials and methods: This multicentre phase 3 trial included a 24‐week, randomized, double‐blind, placebo‐controlled period, followed by a 28‐week extension period. Patients (N = 421) with HbA1c of 7.0% or higher and 10.5% or less were randomized (1:1:1) to receive once‐daily placebo, janagliflozin 25 or 50 mg. After the 24‐week treatment period, patients on placebo were re‐randomized (1:1) to janagliflozin 25 or 50 mg for the additional 28‐week treatment, whereas patients on janagliflozin maintained the same therapy. The primary endpoint was the change from baseline in HbA1c to week 24. Results: At week 24, the placebo‐adjusted least squares mean changes of HbA1c were –0.58% and –0.58% with janagliflozin 25 and 50 mg, respectively (P <.0001 for both). The proportion of patients achieving HbA1c less than 7.0% was higher with janagliflozin 25 and 50 mg compared with placebo (41.8%, 41.7% and 28.0%, respectively). Both janagliflozin doses provided significant reductions in fasting plasma glucose, 2‐hour postprandial glucose, body weight and systolic blood pressure, and improvements in high‐density lipoprotein cholesterol and insulin sensitivity compared with placebo (P <.05 for all). The trends in improvement of these variables were retained during the 28‐week extension period. No severe hypoglycaemia occurred throughout the whole 52‐week treatment. Conclusions: Janagliflozin 25 or 50 mg once‐daily added to metformin therapy significantly improved glycaemic control, reduced body weight and systolic blood pressure, improved high‐density lipoprotein cholesterol and insulin sensitivity, and was generally well‐tolerated by Chinese T2D patients who had poor glycaemic control with metformin monotherapy. [ABSTRACT FROM AUTHOR]

Aim: To report the rationale for using PB‐201, a partial glucokinase activator (GKA), for a Phase 3 study (NCT05102149) assessing its efficacy and safety in a Chinese population and to describe the design of this GKA Phase 3 trial, the first to involve both an active control and a placebo control arm. Materials and methods: This is an ongoing, multicentre, randomized, double‐blind, three‐arm placebo and active control study to be carried out among 672 Chinese treatment‐naive participants with type 2 diabetes mellitus (T2DM) to assess the efficacy and safety of PB‐201 for approximately 60 weeks, including a screening period and a safety follow‐up period. Results: The primary objective of this study was to monitor change in glycated haemoglobin levels with PB‐201 in treatment‐naive T2DM participants from baseline to 24 weeks in comparison with vildagliptin and placebo. The key secondary objective was to assess the efficacy and safety of PB‐201 following treatment for a time period of 52 weeks. Conclusion: This pivotal study will offer critical information regarding the efficacy and safety of PB‐201 in Chinese treatment‐naive T2DM participants that would help to establish robust evidence for the benefit‐risk evaluation of this drug. [ABSTRACT FROM AUTHOR]

Blood glucose monitoring is an important part of diabetes management. Continuous glucose monitoring (CGM) technology has become an effective complement to conventional blood glucose monitoring methods and has been widely applied in clinical practice. The indications for its use, the accuracy of the generated data, the interpretation of the CGM results, and the application of the results must be standardized. In December 2009, the Chinese Diabetes Society (CDS) drafted and published the first Chinese Clinical Guideline for Continuous Glucose Monitoring (2009 edition), providing a basis for the standardization of CGM in clinical application. Based on the updates of international guidelines and the increasing evidence of domestic studies, it is necessary to revise the latest CGM guidelines in China so that the recent clinical evidence can be effectively translated into clinical benefit for diabetic patients. To this end, the CDS revised the Chinese Clinical Guideline for Continuous Glucose Monitoring (2012 Edition) based on the most recent evidence from international and domestic studies. [ABSTRACT FROM AUTHOR]

Background: Needle free insulin injector is designed for diabetics with needle anxiety or fear of injection pain resulting in reluctance to initiate insulin therapy when it is actually indicated. This device has faster absorption of insulin and has better glycemic control compared with conventional insulin pen. But the efficacy of glycemic control was only evaluated by postprandial blood glucose or the area under blood glucose curve. Objective: To investigate the efficacy of needle free insulin injector by HbA1c level compared with conventional insulin pen in insulin treated type 2 diabetic patients in multicenter, prospective, randomized, open-label trial. Methods: A total of 427 patients with HbA1c levels of ≥7.5% to ≤11% while receiving basal or premixed insulin were randomized 1:1 to needle free insulin injector group (NFII) or conventional insulin pen group (CIP). The primary efficacy endpoint was change of HbA1c leve after 16 weeks treatment. The change of 7-point blood glucose profile and the percentage of patients with HbA1c level <7% were also observed. Results: Of the 412 patients (mean age 57.92±10.03ys; BMI 28.33±2.96kg/m2; HbA1c 8.25±1.00%) who completed the study, 206 patients were insulin treated via NFII and 206 via CIP. There were no significant differences in baseline characteristics between the two groups (P> 0.05). The HbA1c reduction 0.55% (95% CI: -0.71, -0.39) at week 16 in NFII group was non-inferior and statistically superior compared with that of 0.26% (95% CI: -0.42, -0.11) in CIP group. There were no differences between two groups in the percentages of patients achieving the HbA1c target (27.32% vs. 24.26%; P> 0.05) or in the change of 7-point blood glucose profile at week 16. Conclusions: The device non-inferior and statistically superior efficacy in glycemic control compared to conventional insulin pen in insulin-treated type 2 diabetic Patients in China. Disclosure: L. Gao: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. L. Guo: None. Y. Wang: None. L. Chen: Research Support; Self; Becton, Dickinson and Company. G. Wang: None. X. Ran: None. X. Xu: None. Z. Sun: None. Z. Ma: None. Z. Shan: None. [ABSTRACT FROM AUTHOR]

Context: Maturity-onset diabetes of the young 4 (MODY4) is caused by mutations of PDX1; its prevalence and clinical features are not well known., Objective: This study aimed to investigate the prevalence and clinical characteristics of MODY4 in Chinese people clinically diagnosed with early-onset type 2 diabetes (EOD), and to evaluate the relationship between the PDX1 genotype and the clinical phenotype., Method: The study cohort consisted of 679 patients with EOD. PDX1 mutations were screened by DNA sequencing, and their pathogenicity was evaluated by functional experiments and American College of Medical Genetics and Genomics guidelines. MODY4 was diagnosed in individuals with diabetes who carry a pathogenic or likely pathogenic PDX1 variant. All reported cases were reviewed for analyzing the genotype-phenotype relationship., Result: 4 patients with MODY4 were identified, representing 0.59% of this Chinese EOD cohort. All the patients were diagnosed before 35 years old, either obese or not obese. Combined with previously reported cases, the analysis revealed that the carriers of homeodomain variants were diagnosed earlier than those with transactivation domain variants (26.10 ± 11.00 vs 41.85 ± 14.66 years old, P < .001), and the proportions of overweight and obese individuals with missense mutation were higher than those with nonsense or frameshift mutations (27/34 [79.4%] vs 3/8 [37.5%], P = .031)., Conclusion: Our study suggested that MODY4 was prevalent in 0.59% of patients with EOD in a Chinese population. It was more difficult to identify clinically than other MODY subtypes owning to its clinical similarity to EOD. Also, this study revealed that there is some relationship between genotype and phenotype., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)