Therapeutic options for elderly diabetic subjects: open label, randomized clinical trial of insulin glargine added to oral antidiabetic drugs versus increased dosage of oral antidiabetic drugs

Abstract

Glycemic control in elderly persons with type 2 diabetes mellitus (T2DM) is challenging because they are more likely to have other age-associated medical conditions and to experience hypoglycemia during intensive therapy. A best therapeutic strategy for these patients has not yet been defined. We investigated the efficacy and safety of adding once-daily insulin glargine to patients' current oral antidiabetic drugs (OAD) regimen, compared to increasing the OAD doses. The study enrolled patients aged 65 years or more, with poor glycemic control. Patients were randomized to two groups and entered a 3-week titration period in which their actual therapy was adjusted to meet the study's glycemic goals, by either adding insulin glargine to current therapy (group A, 27 patients) or increasing current OAD dosages (group B, 28 patients). Thereafter, therapies were continued unchanged for a 24-week observation period. The mean therapeutic dosage of insulin glargine in group A was 14.9 IU/day (SD = 5.0 IU/day). During the observation period, mean levels of glycosylated hemoglobin (HbA1c) reduced by 1.5% in group A and 0.6% in group B (P = 0.381). An HbA1c level <7.0% was achieved by five patients in each group. Mean fasting blood glucose levels reduced by 29 and 15% in groups A and B, respectively (P = 0.029). Group A had fewer total hypoglycemic events (23 vs. 79, P = 0.030) and fewer patients experiencing any such event (9 vs. 17, P = 0.045). Neither a serious hypoglycemic event nor other adverse event occurred. These results suggest that, compared to increasing OAD dosage, the addition of insulin glargine to current OAD therapy is as effective but safer in terms of the risk for hypoglycemia in elderly patients with T2DM.

Persistence with rapid-acting insulin and its association with A1C level and severe hypoglycemia among elderly patients with type 2 diabetes

“…The finding of a low risk of hypoglycemia associated with insulin use is in line with other studies that reported lower hypoglycemia risk with insulin added to OADs compared with OADs alone 29 or no increase in hypoglycemia with insulin compared with OADs 30,31 . This finding has implications for programs and interventions focused on reducing barriers to RAI initiation and persistence, as the fear of adverse effects (such as hypoglycemia) is one of the reasons for not initiating insulin therapy among both physicians and patients 32–35 .…”

The economic and clinical benefits of adequate insulin initiation and intensification in people with type 2 diabetes mellitus

“…The FPG levels were similar at baseline and endpoint for the different types of insulin [19]. A substantial reduction in BG levels was reported when insulin was added to OADs compared to OADs alone [22]. QoL/TS.…”

Achieving glycemic control in elderly patients with type 2 diabetes: a critical comparison of current options

“…For elderly diabetic patients with inadequately controlled hyperglycemia, patients with early combinations of basal insulin had better glycemic control and less hypoglycemia than titration of oral antidiabetic drugs 175. In diabetic elders with poorly controlled glycemia, insulin therapy did not result in higher hypoglycemia events if glycemic targets were less stringent 176.…”