Objective: To determine the clinical efficacy of Polyethylene Glycol Loxenatide in the treatment of obese or overweight Type 2 Diabetes mellitus (T2DM) patients.
Study design: A randomised-controlled trial. Place and Duration of the Study: Department of Endocrinology, Baoding No. 1 Central Hospital, Hebei, China, from January 2020 to January 2022.
Methodology: One hundred overweight and obese patients who were diagnosed with T2DM were prospectively included. They were randomly divided into two groups, with 50 cases in each group. The control group was given oral metformin + subcutaneous insulin injection. The combined treatment group was also given Polyethylene Glycol Loxenatide in addition to the control treatment. The duration of treatment was 6 months for both groups. The clinical efficacy of the two group treatments was compared. The height, body mass, weight index (body mass index (BMI)), total cholesterol (TC), 2-h postprandial blood glucose (2hPBG), high-density lipoprotein cholesterol, fasting insulin (FINS), lipids (triglycerides (TG), low-density lipoprotein cholesterol, homeostasis model assessment of insulin resistance (HOMA-IR) levels, fasting blood glucose (FPG), and glycosylated haemoglobin (HbAlc) were evaluated before and 6 months after the treatment. In addition, any adverse reactions in the two groups were observed.
Results: The overall effective rate of clinical therapy was 92% (46/50) in the combined treatment group, which was higher than that of the control group (76%, 38/50, p = 0.029). The weight and BMI levels of the combined treatment group became considerably lower than those of the control group (weight p = 0.004; BMI p <0.001), and the levels of FPG, 2hPBG, FINS, HbAlc and HOMA-IR (all p = <0.001), and the TG and TC values decreased in both groups (TG p = 0.001; TC p = 0.016).
Conclusion: PEG Loxenatide considerably affects obese and overweight T2DM patients. With no noticeable adverse reactions, this drug is highly recommended for application and clinical promotion.
Key words: Polyethylene Glycol Loxenatide, Type 2 Diabetes mellitus, Obesity, Overweight, Clinical efficacy.