The Long-Term Efficacy of Insulin Glargine Plus Oral Antidiabetic Agents in a 32-Month Observational Study of Everyday Clinical Practice

Abstract

Maintaining target glycosylated hemoglobin (HbA(1c)) (<7%) in patients with type 2 diabetes mellitus (T2DM) reduces the risk of late diabetes-associated complications. Previously reported results of a 9-month, uncontrolled, observational study (n = 12,216) showed that the addition of insulin glargine, a basal insulin analog, to existing oral antidiabetic drug (OAD) therapy was associated with reductions in HbA(1c) to target levels. This analysis investigated the effects of long-term, once-daily insulin glargine plus OAD therapy on glycemic control in patients with T2DM in a 32-month extension of the original observational study. After 9 months of observation, an extension of up to 32 months was offered to the participating physicians. The 32-month data were available for 1,915 patients. At baseline, mean +/- standard deviation age was 63.5 +/- 11.3 years, HbA(1c) was 8.6 +/- 1.5%, fasting blood glucose (FBG) level was 200.7 +/- 57.8 mg/dL (11.1 +/- 3.2 mmol/L), and body mass index (BMI) was 29.0 +/- 4.8 kg/m(2). Reductions in HbA(1c) (-1.7%) and FBG (-71.4 mg/dL [-4.0 mmol/L]) were observed after 9 months of treatment with insulin glargine plus OADs and were maintained at 32 months (HbA(1c), -1.6%; FBG, -71.8 mg/dL [-4.0 mmol/L]). These improvements were broadly consistent across all BMI categories. These data suggest that in daily practice the introduction of insulin glargine with continued OAD therapy facilitates both attainment and maintenance of target HbA(1c) levels, irrespective of BMI in patients with T2DM.