Sitagliptin compared with glimepiride combined with metformin as an initial therapy in newly diagnosed diabetes patients with severe hyperglycaemia: A randomized controlled non-inferiority study
- VernacularTitle:西格列汀与格列美脲联合二甲双胍治疗初诊2型糖尿病并高糖毒性患者的有效性及安全性比较：一项随机对照非劣效性研究
- Author:
Mingqian HE
1
;
Jingya WANG
1
;
Mei DENG
2
;
Bingyin SHI
1
;
Jing SUI
3
Author Information
- Publication Type:Journal Article
- Keywords: type 2 diabetes mellitus; severe hyperglycemia; sitagliptin; glimepiride
- From: Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(1):86-92,98
- CountryChina
- Language:Chinese
- Abstract: 【Objective】 To investigate the efficacy and safety of sitagliptin combined with metformin versus glimepiride combined with metformin in newly diagnosed type 2 diabetes patients with severe hyperglycaemia. 【Methods】 A randomized controlled and non-inferiority trial was carried out. A total of 129 newly diagnosed type 2 diabetes patients with severe hyperglycaemia [FPG≥200 mg/mL (11.1 mmol/L) and HbA1c≥9.0%] were enrolled and numerally randomly assigned to two groups. The patients received sitagliptin combined with metformin (n=66) or glimepiride combined with metformin (n=63) for 4 weeks and then metformin alone for another 8 weeks. Glycaemic control, weight changes and β-cell insulin secretory capacity were investigated to demonstrate the efficacy and safety of these two treatments. 【Results】 Mean HbA1c reduction was 4.03% in sitagliptin group and 4.13% in glimepiride group after 3 months of treatment. The lower boundary of the two-sided 95% confidence intervals of the mean HbA1c reduction difference between the two groups was -0.648%, which was more than -0.65%, suggesting that the predefined statistical criterion for non-inferiority was achieved. FPG decreased significantly after one month of intervention in both groups (P<0.05). Significant reduction in the time of reaching euglycemia, FPG and weight decrease was observed in sitagliptin group than glimepiride group (P<0.05). The FPG control rate FPG<110 mg/mL (6.1 mmol/L) was higher in sitagliptin group than in glimepiride group (P<0.05). After the 3-month follow-up, FPG, HbA1c and incidence of hypoglycemia showed no significant differences in the two groups, while weight loss and BMI changes showed significant differences in sitagliptin group compared with glimepiride group (P<0.05). No significant differences in β-cell insulin secretory indexes were observed in the two therapy groups (P>0.05). 【Conclusion】 Our study provided evidence that sitagliptin combined with metformin in newly diagnosed diabetes patients with severe hyperglycaemia showed better outcomes in glycaemic remission compared with glimepiride for those who refused insulin injection.
