Evaluation of stepwise insulin treatment as an add-on to current oral antidiabetic drugs therapy in Japanese patients with type 2 diabetes: STEADY study

Purpose To assess whether stepwise insulin treatment in addition to current oral antidiabetic drug (OAD) therapy is useful for achieving the Japan Diabetes Society glycemic target (HbA1c <6.9 %) for Japanese patients with type 2 diabetes. Materials and methods This multi-center, open-label, observational study included type 2 diabetes patients with inadequate glycemic control (HbA1c 7.4–10.4 %) by more than 1 OAD. A once-daily injection of insulin detemir was initiated (phase 1); the dose was titrated in accordance with the fasting blood glucose level of self-monitored blood glucose (SMBG). After 6 months, if the HbA1c target was not achieved, a once-daily injection of insulin aspart was administered before the main meal for 6 months (phase 2); its dose was titrated in accordance with postprandial blood glucose level of SMBG. Results Forty-nine patients were enrolled, and 43 patients (mean age 61.6 years, mean diabetes duration 15.7 years, mean body mass index 25.7 kg/m 2 ) completed the study. After phase 1, mean HbA1c decreased from 8.4 to 7.8 % ( p < 0.001), and 14.0 % (6/43) of the patients achieved the HbA1c target. After phase 2, mean HbA1c decreased from 8.4 to 7.8 % ( p = 0.001), and the HbA1c target was achieved by 16.2 % (6/37) of those who did not reach the HbA1c target in phase 1. Conclusions Initiation of once-daily basal insulin and addition of once-daily bolus insulin significantly reduced mean HbA1c but did not satisfactorily achieve the HbA1c target for insulin-naive patients with type 2 diabetes and inadequate glycemic control by OADs.