A randomized controlled trial Polyethylene Glycol Loxenatide Injection for patients with type 2 diabetes mellitus
LI Lei1 WANG Fei1 LI Min2 JIANG Sheng1▲
1.Department of Endocrinology, First Affiliated Hospital of Xinjiang Medical University, Xinjiang Uygur Autonomous Region, Urumqi 830054, China; 2.Department of Endocrinology, Ingisha People’s Hospital, Xinjiang Uygur Autonomous Region, Ingisha 844500, China
Abstract：Objective To investigate the efficacy and safety of Polyethylene Glycol Loxenatide Injection (PEX-168) injection in the treatment of type 2 diabetes. Methods A total of 60 patients with type 2 diabetes mellitus in our hospital from August 2018 to August 2019 were randomly divided into two groups, they were divided into the L group and C group according to the random number table, with 30 cases in each group. Group C was given Metformin tablet 0.5 g/time, twice a day; Acarbose 25 mg/time, 2-3 times/day. Patients in group L were subcutaneously injected with PEX-168 0.5 ml/dose in the upper arm once a week for 12 weeks on the basis of group C during the treatment period. Four weeks after the end of the treatment period, fasting blood glucose, 2 h postprandial blood glucose and hemoglobin ALC (HbA1c) and bady mass index(BMI) were measured. The occurrence of adverse reactions such as hypoglycemia, nausea, vomiting, abdominal discomfort and headache in the two groups were recorded. Results The fasting blood glucose, 2 h postprandial blood glucose, HbA1c and BMI of the L group were significantly lower after treatment than before, with statistically significant differences (P ＜ 0.05). Fasting blood glucose, 2 h postprandial glucose, HbA1c and BMI in the L group were significantly lower than those in the C group after treatment, with statistically significant differences (P ＜ 0.05). After treatment, the number of patients in group L with HbA1c ＜ 7.0% was significantly more than that in group C, with a statistically significant difference (P ＜ 0.05). There was no significant difference in the incidence of hypoglycemia, headache, vomiting and abdominal discomfort between the two groups (P ＞ 0.05). Conclusion PEX-168 Injections has high efficacy and safety in the treatment of type 2 diabetes, but the gastrointestinal reactions of patients should be observed.
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