Xi Chen1, Yongping Xu1, Jianhua Zhang1, Shiyin Shao1, Yanran Duan2, Peiwen Liu3, Liya Shen4, Jing Zhang5, Jiaoe Zeng6, Mei Lin7, Shi Zhao8, Jianhua Ma9, Tao Zhao10, Juping Hu11, Yong Liao12, Xiaowen Chen13, Shufang Hu14, Yaoming Xue15, Zhaoyang Zeng16, Wentao He1, Zhelong Liu1, Wenjun Li17, Liegang Liu18, Ping Yin2, Xuefeng Yu19. 1. Division of Endocrinology, Branch of National Clinical Research Center for Metabolic Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 2. Department of Epidemiology and Health Statistics, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 3. Clinic of Peiwen Liu, Xinhua Hospital, Wuhan, China. 4. Division of Endocrinology, Department of Internal Medicine, Wuhan Sixth Hospital, Wuhan, China. 5. Division of Endocrinology, Department of Internal Medicine, Combine Traditional Chinese and Western Medicine Hospital, Wuhan, China. 6. Division of Endocrinology, Department of Internal Medicine, Jingzhou Central Hospital, Jingzhou, China. 7. Division of Endocrinology, Department of Internal Medicine, Wuhan PuAi Hospital, Wuhan, China. 8. Division of Endocrinology, Department of Internal Medicine, Wuhan Central Hospital, Wuhan, China. 9. Division of Endocrinology, Department of Internal Medicine, Nanjing First Hospital, Nanjing, China. 10. Division of Endocrinology, Department of Internal Medicine, Xiaogan Central Hospital, Xiaogan, China. 11. Division of Endocrinology, Department of Internal Medicine, The Third People's Hospital of Hubei Province, Wuhan, China. 12. Division of Endocrinology, Department of Internal Medicine, The Armed Police General Hospital, Chongqing, China. 13. Division of Endocrinology, Department of Internal Medicine, Huangshi Central Hospital, Huangshi, China. 14. Division of Endocrinology, Department of Internal Medicine, Hankou Railway Hospital. Wuhan, China. 15. Division of Endocrinology, Department of Internal Medicine, Nanfang Hospital, Southern Medical University. Guangzhou, China. 16. Division of Endocrinology, Department of Internal Medicine, Yichang Central Hospital, Yichang, China. 17. Computer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 18. Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 19. Division of Endocrinology, Branch of National Clinical Research Center for Metabolic Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Electronic address: xfyu188@163.com.
Abstract
OBJECTIVE: Many patients with type 2 diabetes treated with premixed insulin gradually have inadequate glycemic control and switch to a basal-bolus regimen, which raises some concerns for weight gain and increased hypoglycemic risk. Switching to combination use of glp-1 agonist and basal insulin may be an alternative option. METHODS: After a 12-week premixed human insulin 70/30 dosage optimization period, 200 patients with HbA1c of 7.0% to 10.0% were randomized into 24-week treatment groups with exenatide twice a day plus glargine or with aspart 70/30 twice a day. RESULTS: After 24 weeks, the patients receiving exenatide plus glargine (n = 90) had improved HbA1c control compared with those receiving aspart 70/30 (n = 90) (least squares mean change: ‒0.59 vs ‒0.13%; difference [95% CI]: ‒0.45 [‒0.74 to ‒0.17]) in the full analysis set population. Weight decreased 3.5 kg with exenatide and decreased 0.4 kg with aspart 70/30 (P < .001). The insulin dose was reduced 10.7 units/day (95% CI, ‒12.2 to ‒9.2 units; P < .001) with exenatide, and increased 9.7 units/day (95% CI, 8.2 to 11.2 units; P < .001) with aspart 70/30. The most common adverse events were gastrointestinal adverse effects in the exenatide group (nausea [21%], vomiting [16%], diarrhea [13%]). The incidence of hypoglycemia was similar in 2 groups (27% for exenatide and 38% for aspart 70/30; P = .1). CONCLUSION: In premixed human insulin‒treated patients with type 2 diabetes with inadequate glycemic control, switching to exenatide twice a day plus glargine was superior to aspart 70/30 twice a day for glycemic and weight control.
OBJECTIVE: Many patients with type 2 diabetes treated with premixed insulin gradually have inadequate glycemic control and switch to a basal-bolus regimen, which raises some concerns for weight gain and increased hypoglycemic risk. Switching to combination use of glp-1 agonist and basal insulin may be an alternative option. METHODS: After a 12-week premixed human insulin 70/30 dosage optimization period, 200 patients with HbA1c of 7.0% to 10.0% were randomized into 24-week treatment groups with exenatide twice a day plus glargine or with aspart 70/30 twice a day. RESULTS: After 24 weeks, the patients receiving exenatide plus glargine (n = 90) had improved HbA1c control compared with those receiving aspart 70/30 (n = 90) (least squares mean change: ‒0.59 vs ‒0.13%; difference [95% CI]: ‒0.45 [‒0.74 to ‒0.17]) in the full analysis set population. Weight decreased 3.5 kg with exenatide and decreased 0.4 kg with aspart 70/30 (P < .001). The insulin dose was reduced 10.7 units/day (95% CI, ‒12.2 to ‒9.2 units; P < .001) with exenatide, and increased 9.7 units/day (95% CI, 8.2 to 11.2 units; P < .001) with aspart 70/30. The most common adverse events were gastrointestinal adverse effects in the exenatide group (nausea [21%], vomiting [16%], diarrhea [13%]). The incidence of hypoglycemia was similar in 2 groups (27% for exenatide and 38% for aspart 70/30; P = .1). CONCLUSION: In premixed human insulin‒treated patients with type 2 diabetes with inadequate glycemic control, switching to exenatide twice a day plus glargine was superior to aspart 70/30 twice a day for glycemic and weight control.