It may come as a surprise that even though approximately 25% of adults older than age 65 have diabetes, this age group is dramatically under-represented in clinical trials. Indeed, almost one-third of interventional trials have age > 65 as an exclusion! Therefore, it is heartening to see a clinical trial specifically addressing seniors (mean age 75 years) with type 2 diabetes (DM2).
Barnett et al studied DM2 patients who were not at goal (mean A1c = 7.8%) despite treatment with metformin, sulfonylurea, and basal insulin (alone or in combination). Study subjects were randomized to linagliptin 5 mg/d or placebo, and followed for 6 months. The primary endpoint was change in A1c.
Treatment with linagliptin was both effective (mean placebo-adjusted A1c decline = -0.64%) and safe. No serious adverse events related to the study drug occurred; although there was a trend for more hypoglycemic events in the linagliptin arm of the study, the results did not reach statistical significance.
It is reassuring to see that seniors can attain greater glucose control in a safe fashion. [Note: this was an industry sponsored study by Boehringer Ingelheim, makers of linagliptin.]
Source: Barnett AH, et al. Linagliptin for patients aged 70 years or older with type 2 diabetes inadequately controlled with common antidiabetes treatments: A randomised, double-blind, placebo-controlled trial. Lancet 2013;382:1413-1423.