ABSTRACT
Objective: 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. Research design and methods: 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 center study. Doses were adjusted systematically to obtain target fasting glucose <100 mg/dl. Outcomes included fasting blood sugar, glycosyloted hemoglobin (HbA1C) levels, change in weight and insulin dose from study start to end. Results: At the start of study, age range was 30-70 years, BMI was 26.48 ± 6.3 kg/m2 and HbA1C was 11.9 ± 3.1% (mean ± SD) for both groups. The mean change (means ± SD) in HbA1C from baseline to endpoint was similar in the insulin glargine group (−3.0 ± 1.68%) and the human premix insulin group (−2.89 ± 1.79%) (p = 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.