This real-world, cross-sectional study of individuals with T2D in Tianjin, a metropolis in northern China, examined the epidemiological characteristics, current treatment patterns and glycaemic control status between 2015 and 2019.
This study demonstrated an increasing burden of disease among individuals with T2D, with an upward trend in the prevalence of cardiovascular disease and associated risk factors (hypertension, hyperlipidaemia, obesity) over time, with inpatients having a higher prevalence than outpatients. In contrast, the prevalence of complications (nephropathy, neuropathy, diabetic foot) were generally higher in the outpatients than inpatients, except for diabetic retinopathy. T2D is known to be associated with cardiovascular risk factors, including hypertension, elevated low-density lipoprotein cholesterol levels and obesity, and cardiovascular disease is the most common cause of death among individuals with T2D [14]. A previous retrospective study of people with diabetes in Beijing reported that the most common comorbidities (in ≥ 20% of individuals) were hypertension, coronary heart disease and dyslipidaemia [15]. Similarly, a retrospective study of Japanese people with T2D found that dyslipidaemia, hypertension and cardiovascular disease were among the most common comorbidities/complications [16]. Therefore, comprehensive management is needed in people with T2D to lower blood pressure, lipid levels and body weight through lifestyle modifications and medications in order to reduce the risk of cardiovascular morbidity and mortality [17]. Further, antidiabetic medications that effectively reduce body weight and provide cardiovascular protection (e.g. GLP-1 RAs or sodium-glucose transporter-2 inhibitors) may be beneficial, particularly in individuals with diabetes-related cardiovascular disease [17,18,19].
With regard to treatment patterns in the current study, the most commonly prescribed OADs and injectable therapies were AGIs and premixed insulin, respectively. Regarding differences between outpatients and inpatients, premixed insulin was still the most commonly prescribed injectable therapy among outpatients, while bolus insulin ± OAD(s) and BI + bolus ± OAD(s) were the most commonly prescribed injectable treatment regimens among inpatients. This indicates that inpatients had more complex treatment scenarios than outpatients, with poorer glycaemic control and requiring treatment intensification with BI + bolus insulin during their admission. The use of bolus insulin ± OAD and BI + bolus insulin ± OAD regimens showed an upward trend over time from 2015 (9.6% and 6.0%, respectively) to 2019 (10.1% and 8.7%, respectively). These observations reflect high degree of attention to PPG and are consistent with high carbohydrate consumption among Chinese people (especially in northern cities like Tianjin) [20], which leads to high PPG levels [21]. Of note, a post hoc analysis of pooled data from randomised controlled phase 3 trials of a BI + bolus insulin combination reported that PPG levels in response to carbohydrate consumption were often higher in individuals with T2D from East Asia (i.e. mainland China, Japan, Korea, Hong Kong and Taiwan), South or South-East Asia (i.e. India, Malaysia and Thailand) or the Middle-East (i.e. Lebanon) versus non-Asian regions, such as Australia, Eastern Europe (i.e. Algeria, Bulgaria, Croatia, Czech Republic, Poland, Romania, Russian Federation, Serbia, Slovakia, Turkey and Ukraine), North America (Mexico and the USA), Scandinavia (Denmark, Finland, Norway and Sweden), South Africa and Western or South-Western Europe (i.e. Austria, France and Spain) [22].
In the current study, there was a decreasing trend in the use of premixed insulin and an upwards trend in the use of BI-based regimens over time. These findings are consistent with those of the retrospective Beijing study, which showed decreased use of premixed insulin between 2016 and 2018 (from 60.5% to 52.0%) and increased use of long-acting BI analogues (from 20.8% to 30.0%) [15]. The reason for the decreased use of premixed insulin over time may be due in part to the higher risk of hypoglycaemia associated with the basal component of premixed insulin (i.e. neutral protamine Hagedorn insulin) versus long-acting BI analogues [23]. In addition to hyperglycaemia, hypoglycaemic events may further increase the risk of macrovascular and microvascular diabetic complications [24], and are associated with decreased treatment satisfaction and poor adherence [25]. Moreover, the premixed insulin regimen is more complex than BI-based regimens, requiring two to three injections per day compared with once-daily BIs, and a premix of two insulin components may not be appropriate for all individuals with T2D. The decreasing trend in SU use among inpatients observed in this study (from 17.9% to 16.6%) may also indicate a growing concern for the risk of hypoglycaemia with these agents [26].
Glycaemic control showed improvement between 2015 and 2019 in the current study, with an upward trend in the proportion of individuals achieving an HbA1c < 7% (< 53 mmol/mol), FPG < 7 mmol/l and PPG < 10 mmol/l. These improvements may be the result of increased use of novel agents, including DPP-4 inhibitors and GLP-1 RAs, updated guidelines or increased adherence to guideline-directed management of T2D in this population [27]. Indeed, this analysis showed consistently increased trends in the use of DPP-4 inhibitors and GLP-1 RAs (± OAD or + BI ± OAD), although the proportion of individuals using GLP-1 RAs remained low (< 1%). Despite these improvements, less than half the population had glycaemic control in 2019, with 33.7% of individuals achieving an HbA1c < 7% (< 53 mmol/mol), 26.9% achieving an FPG < 7 mmol/l and 48.2% achieving a PPG < 10 mmol/l. These findings are consistent with those of a previous cross-sectional study in Chinese adults with T2D, which reported glycaemic control rates of 44.3% for HbA1c < 7% (< 53 mmol/mol), 30.7% for FPG < 7 mmol/l and 23.0% for both HbA1c < 7% (< 53 mmol/mol) and FPG < 7 mmol/l [9]. In the Joint Asia Diabetes Evaluation (JADE) Register, a cross-sectional analysis of people with T2D conducted across 11 countries and regions in East Asia (i.e. mainland China, Hong Kong, Korea and Taiwan), South-East Asia (i.e. Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam) and South Asia (i.e. India) between 2007 and 2017, only 16.5% of all individuals achieved an HbA1c < 7% (< 53 mmol/mol) [28].
A similar proportion of outpatients versus inpatients achieved an HbA1c < 7% (< 53 mmol/mol); however, more inpatients versus outpatients achieved an FPG < 7 mmol/l and more outpatients versus inpatients achieved a PPG < 10 mmol/l. Of note, the proportion of outpatients who failed to achieve both FPG and PPG targets or had residual hyperglycaemia showed an increasing trend between 2015 and 2019. Although the proportion of inpatients with residual hyperglycaemia decreased over time, it remained numerically higher than in outpatients.
These observations highlight an unmet need for simple and effective treatments to achieve glycaemic control while minimising the risk of hypoglycaemia. For example, antidiabetic fixed-dose combinations of metformin plus a DPP4 inhibitor, SGLT-2 inhibitor or sulphonylurea provide effective glycaemic control and have been associated with improved patient adherence and decreased treatment costs [29]; therefore, these agents may play an important role in the management of T2D. Of note, the fixed-dose combinations glipizide/metformin, sitagliptin/metformin and dapagliflozin/metformin are currently available in China. In addition, short-acting GLP-1 RAs, such as once-daily lixisenatide and twice-daily exenatide, provide greater slowing of gastric emptying than long-acting GLP-1 RAs, such as once-daily liraglutide and once-weekly exenatide, thereby driving greater reductions in PPG levels [30]. Once-daily lixisenatide has been shown to significantly delay gastric emptying and provide greater reductions in PPG levels compared with once-daily liraglutide when added to optimized BI therapy in German individuals with T2D [31]. Fixed-ratio combinations of a BI with a GLP-1 RA are also associated with improved glycaemic control. For example, insulin glargine/lixisenatide (iGlarLixi) has been shown to improve HbA1c levels in studies of individuals with T2D from East or South-East Asia (i.e. mainland China, Hong Kong, Korea, Malaysia and Taiwan) [32] and of Chinese individuals with T2D who were previously treated with BI [33], with 79.0% and 63.3% achieving an HbA1c < 7% (< 53 mmol/mol) after 24 or 30 weeks of treatment, respectively, and improved 2-h PPG levels compared with insulin glargine or lixisenatide alone. Further, iGlarLixi reduced the incidence of residual hyperglycaemia among Japanese individuals with T2D inadequately controlled on OADs or BI after 26 weeks of treatment [34, 35]. Similarly, insulin degludec/liraglutide (IDegLira) for 26 weeks was associated with achievement of an HbA1c < 7% (< 53 mmol/mol) in 77.0% and 51.0% of Chinese individuals with T2D inadequately controlled OADs or BI, respectively [36, 37], as well as significantly greater reductions in PPG levels after breakfast and lunch compared with insulin degludec alone in those previously treated with OADs [36]. Therefore, metformin-based fixed-dose combinations and BI + GLP-1 RA fixed-ratio combinations represent simple and effective therapeutic strategies in Chinese individuals with T2D that may help address the unmet needs for glycaemic control in this population.
The main strengths of this study were its large sample size, the inclusion of continuous clinical records for the same individuals using a regional electronic medical record database, and our separate analysis of inpatient and outpatient data. The study was limited, however, by selection bias caused by missing data in glycaemic and biometric measurements, which may have influenced the results as analyses were only conducted in those with available laboratory data. In addition, glycaemic control rates may have been underestimated as a result of individuals with poor glycaemic control being admitted to hospital and having more frequent tests. The data collected in this study were limited to individuals living in the Tianjin area between 2015 and 2019, so while the results of this study are likely representative of clinical practice and patient experience in northern China at this time, they may not be generalisable to the broader population of Chinese individuals with T2D. Lastly, there were limited data on GLP-1 RA treatment patterns between 2015 and 2019 because these medications were only reimbursed in China from late 2020 onwards.
In conclusion, this cross-sectional analysis demonstrated improved glycaemic control between 2015 and 2019 among people with T2D in Tianjin, China, reflecting improved treatment patterns over time. Nevertheless, there is still an unmet need for more simple and effective treatments, such as metformin-based fixed-dose combinations and BI + GLP-1 RA fixed-ratio combinations, to facilitate higher rates of glycaemic control among individuals with T2D in China.
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