Challenges for current diabetes management in China revealed by new study

One of the largest studies on basal insulin in China, the ORBIT Study, announced its main results in Beijing. The study explored current practice in the use of basal insulin therapy for type II diabetes in China.

January 10, 2015, Beijing—the main results of the ORBIT study were officially announced in Beijing. This study was initiated by the Chinese Diabetes Society (CDS), conducted and managed by The George Institute for Global Health at Peking University Health Science Center and supported by Sanofi China. ORBIT has taken a period of four years work since 2011, and nearly 20,000 patients were recruited. Its outcome confirmed the utility and safety of basal insulin in clinical treatment in type 2 diabetes; and revealed many challenges facing the clinical application of this valuable therapy in China.

The ORBIT study, “Observational Registry for Basal Insulin Treatment”, is one of the largest studies ever undertaken on basal insulin usage in China. The objective of the study was to evaluate “real world” basal insulin use in the hospital clinic in typical Chinese diabetes patients whose blood sugar could not be controlled by oral medication alone.  

The leader of ORBIT’s research management team, Associate Professor Zhang Puhong from The George Institute for Global Health at Peking University Health Science Center, announced that since this study was launched in 2011, 19894 patients were enrolled from 209 county-level hospitals in eight regions nationwide.  Follow-up was undertaken at three time points over a six month period. The study will provide a valuable, detailed data base for future clinical analysis.

According to Professor Zhang, the ORBIT study indicated that in more than 80% of patients who started basal insulin for the first time a long-acting basal insulin was used. 70% of these patients were treated with glargine insulin. Basal insulin therapy was shown to be safe in the overwhelming majority of patients in the study, and a trend towards improvement in glucose control was observed over the six month period.   The patients weight was remained stable over the course of the study and the incidence of side effects, including hypoglycaemia (low blood sugar), was low.

Professor Ji Linong, the chief physician of the department of endocrinology in Peking University People’s Hospital, was the principal investigator of the ORBIT study.  Explaining the key research outcomes, he mentioned that factors such as late initiation of basal insulin and insufficient dose titration were still affecting the achievement of optimal blood sugar control in diabetics. For example, 55.9% of the study population started using basal insulin with an HbA1c level over 9%,  a level much higher than the level recommended by national guidelines, indicating poor blood sugar control. “It means these patients didn’t realize the advantages of basal insulin at an early stage, and they didn’t adopt a therapeutic regimen of basal insulin in time”, Professor Ji Linong said, “in fact, many research studies have shown that patients who start using basal insulin within two years of diagnosis are more likely to achieve good control, while those people who start using basal insulin after 5 years or more of diabetes have poorer control” The subjects of the  ORBIT study had been diabetic for an average of 6.4 years before they started insulin.

Apart from late initiation of insulin treatment, ORBIT also showed there were practice challenges in effective basal insulin dose titration. Quite a few of the patients (more than 40%) had no dose changes within three months of commencement. Though 60% of patients had dose titration, in many the dose was still insufficient.  Nearly 60% of patients in the study failed to reach the target fasting blood sugar level (7mmol/l).  Only 15.9% of patients achieved a fasting blood sugar level lower than 6mmol/l.

"We can say that China’s healthcare providers and patients aren’t really aware of the therapeutic value and advantages of basal insulin," commented by Professor Ji Linong, "I hope the announcement of ORBIT’s study findings will serve as a wake up call, to Chinese people with diabetes, encouraging the use of basal insulin to manage their blood glucose more reasonably and scientifically." 

The ORBIT team indicated that they hoped the announcement of ORBIT’s study findings would raise healthcare providers’ awareness of “an earlier start to basal insulin therapy, more strict blood glucose goal setting, and reasonable dose titration.”  They also hoped the findings could ultimately help more diabetic patients meet the target blood glucose level.

Professor Zhang Puhong added, “As a non-profit organization focused on medical and health research, The George Institute for Global Health at Peking University Health Science Center is grateful for the support of Sanofi China for the successful completion of this landmark study. Under the leadership of Professor Ji Linong, a high quality of project management and data analysis has been achieved, to international standards. We expect significant changes will ensue in the treatment and management of China diabetes patients with basal insulin.”

Dr. Alex Condoleon, Senior Medical Director of Sanofi China responded: “Sanofi is very proud to have supported the Chinese Diabetes Society in the successful conduct of the ORBIT study. The findings of ORBIT illustrates the challenges facing basal insulin therapy, which means we have many problems to solve. Sanofi will continue to work with Chinese health care providers to improve the management of type II diabetes, following up on our consistent commitment: “patients always come first.”

**Please note that this is an updated version on Jan 16, 2015