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

Abstract

Background:

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.

Methods:

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.

Results:

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/m². 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.

Conclusions:

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.