Glycemic Control With Insulin Glargine Plus Insulin Glulisine Versus Premixed Insulin Analogues in Real-World Practices: A Cost-Effectiveness Study With a Randomized Pragmatic Trial Design

Background: Cost can be an important consideration, along with safety and efficacy, in deciding the most appropriate treatment for patients with type 2 diabetes. Both basal-bolus and premixed insulin analogue regimens are widely used in clinical practice; however, limited information is available regarding cost-effectiveness. Objective: The goal of this study was to compare glycemic control, cost-effectiveness, and quality of life effects of insulin glargine plus insulin glulisine (glargine/glulisine) versus premixed insulin analogues in real-world clinical practice. Methods: Adults with type 2 diabetes (glycosylated hemoglobin [HbA _1c] 7.0%) at 3 US endocrinology centers were randomly assigned to receive either glargine/glulisine or premixed insulin analogues and continued treatment following the centers' usual practice. HbA _1c, weight, insulin dose, concomitant oral antidiabetic drug (OAD) usage, and hypoglycemia were evaluated at baseline and 3, 6, and 9 months. Medication costs, including costs for all insulin or OAD regimens, were estimated using published wholesale acquisition costs. Results: A total of 197 patients were randomized to receive glargine/glulisine therapy (n = 106) or premixed analogue therapy (n = 91). Overall, the mean age was 56 years, the mean duration of diabetes was 13 years, with a mean HbA _1c of 9.25% and mean BMI of 35.8 kg/m ² at baseline. Patients randomized to receive glargine/glulisine had a greater mean HbA _1c reduction from baseline (-2.3%) than patients receiving a premixed analogue regimen (-1.7%). Adjusted mean follow-up HbA _1c was 6.9% versus 7.5%, respectively (difference, -0.59%; P < 0.01). The glargine/glulisine group also used a lower mean number of OADs (0.86 vs 1.14; difference, -0.28; P = 0.04) but had a higher weight (240 vs 235 lb; difference, 4.55 lb; P = 0.03) than the premixed analogue group at follow-up. There were no significant differences in daily insulin dose and rates of hypoglycemia. Overall medication costs per 1.0% reduction in HbA _1c were 841 with glargine/glulisine and 1308 with premixed analogues. Conclusions: Overall, treatment with glargine/glulisine provided greater improvement in glycemic control and may represent a more cost-effective treatment option than premixed regimens for patients with type 2 diabetes in real-world clinical practice. However, due to the pragmatic trial design, the study concluded before follow-up assessments were available for all randomized patients.