This study was conducted to evaluate the efficacy and tolerability of rosiglitazone in the treatment of patients with secondary
oral antidiabetic drug (OAD) failure and to directly compare its use with bedtime insulin. A total of 112 Chinese patients
with type 2 diabetes and conventional OAD failure were recruited. Patients were randomly assigned to treatment with rosiglitazone
or bedtime isophane insulin; they continued to take their original oral antidiabetic drugs. Glycemic index, other clinical
profiles, and tolerability were assessed during treatment and 1 y after add-on treatment was provided. Among the 112 patients,
mean age (±SD) was 58.2±11.0 y (median, 58 y; range, 37 to 84 y). Both rosiglitazone (n=56) and insulin (n=56) significantly
improved fasting glucose (2.4 and 3.7 mmol/L, respectively) and hemoglobin A
1c concentrations (1.1% and 1.3%, respectively). Both therapies increased body mass index after 1 y of treatment (0.9 and 0.8
kg/m
2, respectively). Only rosiglitazone increased high-density lipoprotein cholesterol concentrations (0.1 mmol/L). Four patients
(7.1 %) who were given rosiglitazone developed adverse effects (2, ankle edema, and 2, gastrointestinal disturbance). Six
insulin-treated patients (10.7%) described adverse effects (5, early morning hypoglycemia, and 1, anxiety). Investigators
concluded that in Chinese patients with type 2 diabetes and secondary conventional OAD failure, 1 y of treatment with rosiglitazone
or bed-time insulin added to the regular regimen resulted in similar improvements in glycemic control. Rosiglitazone was also
associated with improved high-density lipoprotein cholesterol levels. The addition of rosiglitazone may offer a safe and effective
alternative to bedtime insulin treatment.
Keywords rosiglitazone - insulin - oral antidiabetic drug - failure - Chinese