Linagliptin may be effective for elderly patients, study finds

Linagliptin appeared efficacious in patients age 70 years or older with type 2 diabetes who didn't achieve glycemic control from other regimens, and it had a safety profile similar to placebo, reported an industry-funded trial.

Researchers conducted a double-blind, parallel-group, multinational phase 3 study in 241 community-living outpatients with hemoglobin A1c (HbA1c) of 7.0% or more who were receiving metformin, sulfonylureas, basal insulin or combinations of these drugs at baseline. Patients were instructed to continue their previous medications. They were stratified by HbA1c level of <8.5% or ≥8.5% and insulin use, and then randomized in a 2:1 ratio to once daily oral linagliptin (n=162) or matching placebo (n=79) for 24 weeks. Results were published online Aug. 13 by The Lancet.

The mean HbA1c at baseline was 7.8% (SD, 0.8%). At week 24, mean change in HbA1c with linagliptin was 0.64% lower than with placebo (95% CI, −0.81 to −0.48; P<0.0001). Overall safety and tolerability were similar between the linagliptin and placebo groups.

Serious adverse events occurred in 6.3% patients in the placebo group (n=5) and 8.6% patients in the linagliptin group (n=14); all were deemed unrelated to linagliptin. Hypoglycemia was the most common adverse event in both groups but did not differ between groups (24.1% [n=39] in the linagliptin group, 16.5% [n=13] in the placebo group; odds ratio, 1.58; 95% CI, 0.78 to 3.78; P=0.2083). There were no deaths.

The researchers noted that the study population was characteristic of elderly patients with type 2 diabetes who are encountered in clinical practice: More than half of the study population had diabetes for 10 years in more; 87% had cardiovascular disease and 79% had renal impairment; and there was a generally high use of concomitant drugs.

They concluded, “Linagliptin might be a useful glucose-lowering drug for elderly patients with type 2 diabetes, a prevalent population for which other treatment options are understudied and have important limitations.”

However, an accompanying editorial stated that the study missed crucial opportunities to examine the management of older patients with type 2 diabetes, especially those who are frail.

“Their description of HbA1c targets is vague and there is no mention of how these targets were discussed, managed, or achieved,” the editorial stated. “Attempts to lower HbA1c towards 7.0% (53 mmol/mol) or less in an older cohort of patients with diabetes might seem unnecessary or even dangerous since higher target levels are now recommended” by international consensus groups and position papers.