English

Abstract

INTRODUCTION: Type 2 diabetes is a progressive disorder of β-cell dysfunction. Patients using oral therapy alone for it seldom achieve and maintain the recommended 7% HbA1c goal for glycemic control. However, the majority of patients with a longer duration of diabetes remain poorly controlled with oral agents, and use of insulin, which could improve glycemic control, is often long delayed and not aggressive enough. Glargine, a long-acting insulin analog with a more favourable 24-h time-action profile (no pronounced peak) than long- or intermediate-acting human insulin preparations, may be especially suited in this condition. AIMS: To compare the safety and efficacy of the long-acting analog insulin glargine and human premix insulin in patients with type 2 diabetes who were previously treated with oral hypoglycemic drugs alone but inadequately controlled. SETTINGS AND DESIGN: A total of 750 subjects with type 2 diabetes who were receiving oral hypoglycemic drugs for diabetes control were randomized to receive insulin glargine once daily (n = 370) or human premix insulin twice daily (n = 380) for 24 weeks in an open-label, tertiary centre study. Doses were adjusted systematically to obtain target fasting glucose < 100mg/dl. Outcomes included fasting blood sugar, HbA1c levels, change in weight and insulin dose from study start to end. STATISTICAL ANALYSIS: Qualitative variables were tested using Chi square test and p values were calculated between two groups. RESULTS: At the start of study, age range was 30-70 years, BMI was 26.48 +/- 6.3 kg/m (2) , and HbA1c was 11.9 +/-3.1%(mean +/- SD) for both group. The mean change (means ± SD) in HbA1c from baseline to end point was similar in the insulin glargine group (−3.0 ± 1.68%) and the human premix insulin group (−2.89 ± 1.79%) (P value =0.3861). The symptomatic hypoglycemic episodes were greater with human premix insulin than with glargine (significance level 0.00002).Subjects in the insulin glargine group experienced less weight gain than those in the premix human insulin group (0.4 vs. 1.4 kg, P < 0.0001). CONCLUSIONS: In patients with type 2 diabetes, once-daily bedtime insulin glargine is as effective as twice-daily human premix insulin in improving and maintaining glycemia control. In addition, insulin glargine demonstrates a lower risk of symptomatic hypoglycemia and less weight gain compared with human premix insulin. The treatments were associated with similar reductions in fasting glucose levels and HbA1c levels.