A pragmatic study of mid-mixture insulin and basal insulin treatment in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic medications: A lesson from real-world experience

Abstract

Background: Chinese guidelines for the treatment of type 2 diabetes (T2D) recommend basal or premixed insulins as insulin starters after failed oral antihyperglycaemic medication (OAM). This pragmatic study compared effectiveness and safety of add-on basal insulin analog (BI) and mid-mixture insulin analog (MMI; 50:50 premixed insulin) as starter insulin regimens in Chinese patients with T2D in a real-world setting.

Materials and methods: This was a multicentre, open-label, randomized, parallel, pragmatic trial. Patients receiving OAMs were randomized 1:1 to BI (n = 410) or MMI (n = 404) for 24 weeks. Insulin titration and OAM adjustment were determined by investigators following usual standard-of-care. The primary outcome was change in glycated haemoglobin (HbA1c) from baseline.

Results: Least-squares mean changes in HbA1c from baseline to week 24 were -2.00% and -2.15% for BI and MMI groups, respectively (P = .13). The MMI group demonstrated a greater reduction in concomitant OAM therapies used than BI group (53.8% vs. 35.3%, respectively; P < .001). Very limited daily insulin dose increments were observed from baseline to week 24 in both BI and MMI groups (2.5 U/day and 1.8 U/day, respectively). Although both insulin analogs were well-tolerated without severe hypoglycaemia, small weight gains were seen with both treatments. Higher total hypoglycaemia rates were noticed with the MMI group, while nocturnal hypoglycaemia events were comparable.

Conclusions: In real-world settings, BI and MMI provided similar improvement in glucose control without conceding hypoglycaemia. The BI group received a greater number of OAMs in real-world settings. Limited insulin dose titration was observed, while more adjustments occurred with OAM usage.

Keywords: China; insulin; pragmatic trials; type 2 diabetes mellitus.