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

AIMS: Chinese guidelines for treatment of type 2 diabetes (T2D) recommend basal or premixed insulins as insulin starters after failed oral antihyperglycemic 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 multicenter, 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 hemoglobin (HbA1c) from baseline. RESULTS: Least squares (LS) mean changes in HbA1c from baseline to week 24 were - 2.00% and - 2.15% for BI and MMI groups, respectively (P = 0.13). The MMI group demonstrated greater reduction in concomitant OAM therapies used than BI group (53.8% vs 35.3%, respectively; P < 0.001). 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 hypoglycemia, small weight gains were seen with both treatments. Higher total hypoglycemia rates were noticed with the MMI group; while nocturnal hypoglycemia events were comparable. CONCLUSIONS: In real-world settings, BI and MMI provided similar improvement in glucose control without conceding hypoglycemia. 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03018938. This article is protected by copyright. All rights reserved.