Basal‐prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24‐week randomized non‐inferiority trial: 接受基础胰岛素优化治疗之后需要胰岛素强化治疗的患者使用基础‐餐时胰岛素治疗与使用预混胰岛素治疗的对照试验:一项为期24周的随机非劣性试验

Abstract

Background: The aim of the present 24‐week multicentre randomized non‐inferiority trial was to compare the efficacy and safety of two insulin intensification strategies in uncontrolled type 2 diabetes despite optimized basal insulin therapy. Methods: Patients with fasting plasma glucose (FPG) <130 mg/dL and HbA1c 7.0%–10.0% while on insulin glargine were randomized to a basal‐prandial group (stepwise addition of insulin glulisine) or a premixed insulin group (insulin aspart/insulin aspart protamine 30/70 starting with 6 IU twice daily). The primary endpoint was the change in HbA1c after 24 weeks (non‐inferiority margin 0.4%). Results: At Week 24, the adjusted mean change from baseline HbA1c was –0.94 ± 0.09% and –1.04 ± 0.09% in basal‐prandial and premixed insulin groups, respectively, with a mean difference of –0.09% (95% confidence interval [CI] –0.35, 0.16). A lower rate of hypoglycemia with a similar reduction in HbA1c was observed during stabilization of the total daily insulin dose in the premixed insulin group (Weeks 0–12). After stabilization of the total daily insulin dose, the rate of hypoglycemia and the total daily insulin dose were similar in the two groups. Conclusions: The efficacy and safety of the two intensifying regimens were similar after stabilization of the total daily insulin dose when oral agents were maintained. Starting with a lower total daily insulin dose with a gradual change in the treatment regimen was helpful in reducing the rate of hypoglycemia during initial stabilization of the total daily insulin dose.