Clinical trial of linagliptin tablets combined with metformin tablets in the treatment of newly diagnosed type 2 diabetes mellitus
10.13699/j.cnki.1001-6821.2019.07.010
- VernacularTitle:利格列汀片联合二甲双胍片治疗初诊2型糖尿病的临床研究
- Author:
Ting-Ting SUN
1
;
Wei HAO
;
Ming-Ming LI
;
Li LU
;
Hong-Qi FAN
Author Information
1. 枣庄矿业集团中心医院 内分泌科
- Keywords:
linagliptin tablet;
metformin tablet;
newly diagnosed type 2 diabetes mellitus;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2019;35(7):633-636
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of linagliptin tablets combined with metformin tablets in the treatment of newly diagnosed type 2 diabetes mellitus (T2 DM) . Methods A total of 166 patients with newly diagnosed T2 DM were randomly divided into control and treatment groups with 83 cases per group. Control group was treated with metformin tablets 0. 5 g per time, tid, orally. Treatment group was treated with linagliptin tablets 5 mg per time, qd, orally, on the basis of control group. Two groups were treated for 3 months. The clinical efficacy, blood glucose levels, insulin resistance indexes (HOMA-IR) and islet β-cell function indexes (HOMA-β) , and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 91. 57％ (76 cases/83 cases) and 72. 29％ (60 cases/83 cases) with significant difference (P < 0. 05) . After treatment, the main indexes of treatment and controlgroups were compared: the fasting plasma glucose were (6. 18 ± 0. 85) and (7. 27 ± 1. 03) mmol·L-1, postprandial2 h blood glucose were (7. 96 ± 1. 07) and (9. 74 ± 1. 27) mmol · L-1, the glycosylated hemoglobin were (6. 39 ± 0. 77) ％ and (7. 15 ± 1. 02) ％, the HOMA-IR were (1. 47 ± 0. 21) and (2. 35 ± 0. 33) , the HOMA-βwere (26. 39 ± 3. 75) and (19. 62 ± 2. 71) , the differences were statistically significant (all P < 0. 05) . The adverse drug reactions of two groups were nausea and vomiting, diarrhea, dizziness and fatigue. The total incidences of adverse drug reactions in the treatment and control groups were 14. 46％ and 10. 83％ without significant difference (P> 0. 05) . Conclusion Linagliptin tablets combined with metformin tablets have a definitive clinical efficacy in the treatment of newly diagnosed T2 DM, which can significantly reduce the level of plasma glucose, improve the function of islet β-cell, reduce insulin resistance, without increasing the incidence of adverse drug reactions.
