Objective: This study aimed to compare glycemic control and risk of cardiovascular outcomes of metformin-insulin versus metformin-sulfonylurea combination therapies in type 2 diabetes mellitus.
Methods: We conducted a comparative cross-sectional study in five tertiary level hospitals in Addis Ababa, Ethiopia. We enrolled 321 patients with type 2 diabetes mellitus who were on continuous treatment follow-up on either metformin-insulin or metformin-sulfonylurea combination therapy. We interviewed the participants and reviewed their medical records to investigate medication efficacy, safety, and adherence. The primary outcome measure was glycemic control and the secondary outcome measures were composite cardiovascular outcomes.
Results: Of the total participants enrolled, 50.5% (n = 162) were those who received metformin-insulin and 49.5% (n = 159) metformin-sulfonylurea combination therapies for a median of 48 months follow-up. The reduction of Hb1Ac levels was comparable between the metformin-insulin (− 1.04 ± 0.96%) and metformin-sulfonylurea (− 1.02 ± 1.03%), p = 0.912. Patients who received metformin-sulfonylurea had 4.3 times more likely to have achieved target HbA1c level compared to those who received metformin-insulin, p < 0.001, adjusted odds ratio (AOR) with 95% CI = 4.31[1.79– 10.32]. Risk of composite cardiovascular outcomes was higher in metformin-insulin group (40.5% versus 34.0%), p = 0.021. Co-morbidities, body mass index, systolic blood pressure, and HbA1c had a significant association with composite cardiovascular outcomes. Reductions of bodyweight, HDL-C, LDL-C, triglycerides levels, and microvascular complications were different between the two groups, p < 0.05.
Conclusion: High proportion of patients who received metformin-sulfonylurea achieved target HbA1c level and had less composite cardiovascular outcomes compared to those who received metformin-insulin. However, these findings have to be confirmed with randomized control trials to determine risks associated with insulin use, while efficacy is maintained as second-line treatment in patients with type 2 diabetes mellitus.

Keywords: glycemic control, cardiovascular diseases, type 2 diabetes mellitus, metformin, insulin, sulfonylurea, glycated hemoglobin A1c (HbA1c)


中文翻译：

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二甲双胍-胰岛素与二甲双胍-磺脲类联合疗法治疗 2 型糖尿病：埃塞俄比亚亚的斯亚贝巴血糖控制和心血管疾病风险的比较研究

目的：本研究旨在比较二甲双胍-胰岛素与二甲双胍-磺脲类联合治疗 2 型糖尿病的血糖控制和心血管结局风险。
方法：我们在埃塞俄比亚亚的斯亚贝巴的五家三级医院进行了一项横断面比较研究。我们招募了 321 名 2 型糖尿病患者，他们正在接受二甲双胍-胰岛素或二甲双胍-磺脲类联合治疗的持续治疗随访。我们采访了参与者并审查了他们的医疗记录，以调查药物疗效、安全性和依从性。主要结局指标是血糖控制，次要结局指标是复合心血管结局。
结果：在纳入的所有参与者中，50.5%（n = 162）是接受二甲双胍-胰岛素联合治疗的患者，49.5%（n = 159）接受二甲双胍-磺脲类联合治疗，中位随访时间为 48 个月。二甲双胍-胰岛素 (- 1.04 ± 0.96%) 和二甲双胍-磺脲类 (- 1.02 ± 1.03%) 之间的 Hb1Ac 水平降低相当，p = 0.912。与接受二甲双胍-胰岛素治疗的患者相比，接受二甲双胍-磺脲类治疗的患者达到目标 HbA1c 水平的可能性高 4.3 倍，p < 0.001，调整后的优势比 (AOR) 为 95% CI = 4.31[1.79–10.32]。二甲双胍-胰岛素组的复合心血管结局风险更高（40.5% vs 34.0%），p= 0.021。合并症、体重指数、收缩压和 HbA1c 与复合心血管结局显着相关。两组的体重、HDL-C、LDL-C、甘油三酯水平和微血管并发症的降低程度不同，p < 0.05。
结论：与接受二甲双胍-胰岛素治疗的患者相比，接受二甲双胍-磺脲类药物治疗的患者中，高比例的患者达到了目标 HbA1c 水平，复合心血管结局较少。然而，这些发现必须通过随机对照试验得到证实，以确定与使用胰岛素相关的风险，而作为 2 型糖尿病患者的二线治疗，其疗效得以维持。

关键词：血糖控制、心血管疾病、2 型糖尿病、二甲双胍、胰岛素、磺脲类药物、糖化血红蛋白 A1c (HbA1c)