Clinical trial of saxagliptin tablets combined with metformin tablets in the treatment of patients with type 2 diabetes mellitus and atherosclerosis
10.13699/j.cnki.1001-6821.2018.02.002
- VernacularTitle:沙格列汀片联合二甲双胍片治疗2型糖尿病合并动脉粥样硬化的临床研究
- Author:
Chun-Yan XING
1
;
Xiang KONG
;
Li-Bin XIA
;
Jia-Lin GAO
;
Qiang HUA
Author Information
1. 皖南医学院第一附属医院/弋矶山医院内分泌科
- Keywords:
saxagliptin tablet;
metformin tablet;
type 2 diabetes mellitus;
atherosclerosis;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(2):102-104
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of saxagliptin tablets combined with metformin tablets in the treatment of type 2 diabetes mellitus (T2DM) with atherosclerosis (AS).Methods Seventy-four patients with T2DM and AS were randomly divided into control group and treatment group with 37 cases per group.Control group was treated with pioglitazone 15 mg per time,qd,orally + metformin 0.5 g,bid,orally.Treatment group was treated with saxagliptin 5 mg per time,qd,orally + metformin 0.5 g per time,bid,orally.Two groups were treated for 24 weeks.The clinical efficacy,total cholesterol (TC),triacylglycerol (TG),high density lipoprotein cholesterol (HDL-C),low density lipoprotein cholesterol (LDL-C),homeostasis model of assessment for insulin resistance index (HOMA-IR),homeostasis model of assessment for β cell function index(HOMA-β) and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 94.59％ (35 cases/37 cases) and 86.49％ (32 cases/37 eases),without significant difference (P ＞ 0.05).After treatment,the main indexes in treatment and control groups were compared:TC were (3.19 ±0.81) and (3.97 ±0.92) mmol · L-1,TG were (1.34 ±0.28) and (1.60 ± 0.38) mmol · L-1 HDL-C were (1.95 ± 0.32) and (1.78 ± 0.33) mmol · L-1,LDL-C were (1.36 ±0.21) and (1.75 ± 0.36) mmol · L-1,HOMA-IR were 0.54 ±0.19 and 0.84 ±0.15,HOMA-β were 4.53 ± 0.47 and 3.19 ± 0.38,the differences were statistically significant (all P ＜ 0.05).The adverse drug reactions in two groups were gastrointestinal reaction,abnormal liver function and abnormal renal function.The incidences of adverse drug reactions in treatment and control groups were 10.81％ and 13.51％ without significant difference (P ＞ 0.05).Conclusion Saxagliptin tablets combined with metformin tablets have a definitive clinical efficacy in the treatment of T2DM with AS,which can effectively control the levels of blood lipidand and improve the islet beta cell function,without increasing the incidence of adverse drug reactions.
