The clinical application of basal insulin still needs to be improved in China

As one of the largest basal insulin research projects in China, the Observational Registry for Basal Insulin Treatment (ORBIT) project was initiated by the Chinese Diabetes Society (CDS), conducted and managed by The George Institute, China and supported by Sanofi China. ORBIT was launched in 2011 and has successfully published research findings this year after the positive participation of 209 secondary and tertiary hospitals nationwide, hundreds of doctors and follow-up of nearly 20,000 patients with type 2 diabetes for 6 months.

On 22 June 2017, the ORBIT study findings were officially announced in Shenyang. Professor Ji Linong, Director of Endocrinology at Beijing People’s Hospital, Professor Zhou Zhiguang, Director of Research Institute of Endocrinology at The Second Xiangya Hospital of Central South University, Professor Ji Qiuhe, Director of Endocrinology and Metabolism at Xijing Hospital of The Fourth Military Medical University and Professor Zhang Puhong, Associated Director of The George Institute China attended the media conference, discussed clinical status, efficacy and safety of basal insulin for patients with type 2 diabetes in China, and explored solutions to clinical application of basal insulin.

Clinical application is worrying: relatively late starting and inactive dose adjustment
For 19894 patients recruited with type 2 diabetes from all over the country who failed in oral hypoglycemic drug treatment (glycosylated hemoglobin HbA1c>7%), more than half of them had over 9% glycosylated hemoglobin values, and more than thirty percent of them were accompanied with at least one complication. Analysis of patients’ baseline characteristics showed that, the basal insulin treatment was started in time when the baseline blood glucose level was relatively low, and the course of disease and the duration of oral hypoglycemic drugs treatment were shorter, and thus the control rate of glycosylated hemoglobin and fasting blood glucose of patients would be higher. ORBIT findings were consistent with the previous evidence-based research viewpoints - the shorter the duration of diabetes and the lower the glycosylated hemoglobin, the better the patient’s control rate, and the insulin treatment shall be initiated when the glycosylated hemoglobin reached 7.5%.

The average initial dose of basal insulin was only 0.18 ± 0.07 IU/kg d (international unit per kg of body weight per day), with initial basal insulin treatment for 6 months and basal insulin dose increased by only 0.034 IU/kg d; in addition, insulin dose adjustment was not be made for about 40% of patients; insulin dose adjustments have never been made for even about 1/3 of patients with poor blood sugar control (glycosylated hemoglobin greater than 7%). However, previous studies have  suggested that basal insulin efficacy and dose optimization are inseparable, and the glycosylated hemoglobin and fasting blood glucose are gradually improved with the dose adjustment of basal insulin.

"ORBIT study suggested that the onset of insulin treatment in patients with type 2 diabetes in China is late and the dose adjustment is inadequate,” Professor Ji Linong, Director of Endocrinology at Beijing People’s Hospital said. “ORBIT findings also show that patients with type 2 diabetes who are treated with initial basal insulin have a good hypoglycemic effect, very low incidence of severe hypoglycemia and no significant changes in weight. Therefore, starting with analogues of basal insulin treatment may have a better clinical outcome and do not increase treatment costs.”

"Considering that type 2 diabetes is a chronic lifelong disease, patients play an important role in diabetes management, and the basal insulin treatment has a unique advantage for patients participating in blood glucose management because the blood glucose monitoring program is simple and patients can adjust their insulin dose by their own,” added Professor Ji Qiuhe, Director of Endocrinology and Metabolism at Xijing Hospital of The Fourth Military Medical University.

Observational research model, providing data reference and support for clinical treatment
Since 2015, ORBIT research progresses have been published by Professor Ji Linong et al at the National Conference of the Chinese Diabetes Society (CDS) / Annual Meeting of the American Diabetes Association (ADA), causing the extensive attention of various experts in the field of endocrinology. "The observational research is a means of showing the drug effects in the actual clinical environment. It can not only serve as a mutual complementation with randomized controlled studies, but also further verify and support the results of randomized controlled studies, as well as further evaluate the drug safety in clinical applications, so as to provide valuable evidence for evidence-based medicine together," Professor Zhou Zhiguang, Director of Research Institute of Endocrinology at The Second Xiangya Hospital of Central South University, said. “ORBIT research has clear purpose, rigorous design, proper implementation and scientific explanation. It is a model of observational research.”

"As a non-profit organization focused on medical and health research, The George Institute China is always committed to improving the health of millions of people around the world,” Professor Zhang Puhong, Associated Director of The George Institute China said. “Under the leadership of Prof. Ji Linong, with the strong support of Sanofi, ORBIT project has been achieved to international standard. We hope this study will help the patients to better achieve blood sugar target and bring real changes for the utility policy of insulin.”

"In the field of diabetes, Sanofi not only provides patients with high-quality and innovative therapeutic drugs, including basal insulin, but also supports the majority of endocrinology doctors in China with clinical trials,” said Dr. Luo Tianhong, Head of Sanofi China Medical Affairs. “Taking the patient needs as the primary consideration, we focus on how to benefit patients from the quality and efficient therapeutic drugs and scientific health management. Sanofi will continue to promote and enhance the level of clinical diagnosis and treatment of diabetes through multiple ways of clinical research, guidelines promotion, patient education and others, so as to improve quality of life of patients.”

The ORBIT research, “Observational Registry for Basal Insulin Treatment”, is one of the largest basal insulin research projects 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.