medwireNews: The addition of linagliptin to stable insulin treatment improves glycemic control without increasing the risk for clinically important hypoglycemia among older individuals with type 2 diabetes, randomized trial findings suggest.
The phase IV study included 302 participants from 16 countries (approximately one third from Japan), aged an average of 72.4 years, with a mean baseline glycated hemoglobin (HbA1c) level of 8.2%. The study authors note that impaired kidney function “was highly prevalent,” with 85.8% of patients having an estimated glomerular filtration (eGFR) rate below 90 mL/min per 1.73 m2. Over 80% of participants used long-acting insulin analogs as their basal insulin, while approximately two-thirds received metformin in addition to insulin treatment.
As reported in Diabetes, Obesity and Metabolism, average HbA1c levels decreased by 1.01% from baseline to week 24 among the 147 evaluable participants randomly assigned to receive linagliptin 5 mg once daily, compared with 0.38% among the 145 given placebo, translating into a significant adjusted mean difference of 0.63% between the groups.
Gilbert Ledesma (Arlington Family Health Pavilion, Texas, USA) and colleagues say that the dipeptidyl peptidase-4 inhibitor “improved glucose control consistently across subgroups,” with no significant difference in the magnitude of HbA1c reduction when patients were categorized based on age, insulin dose, or kidney function.
Rates of hypoglycemia – defined as blood glucose levels of 70 mg/dL or lower – were numerically higher among participants treated with linagliptin versus placebo, at 30.9% and 23.8%, respectively, but the difference did not reach statistical significance.
The researchers note that this imbalance in hypoglycemia rates between arms “was mainly due to mild, asymptomatic hypoglycemia, as there was no clinically meaningful difference between treatment groups in the proportion of patients experiencing clinically important hypoglycemia.”
Rates of clinically significant hypoglycemia (blood glucose ≤54 mg/dL) were 16.8% and 15.0% in the linagliptin and placebo groups, respectively.
Ledesma et al report that linagliptin was well tolerated overall, with a similar proportion of patients treated with linagliptin or placebo experiencing adverse events (67.5 vs 64.9%). Rates of severe adverse events were numerically lower in the linagliptin arm (4.6 vs 7.9%).
“Overall, linagliptin was well tolerated and our study results thus confirm the established safety and tolerability profile of this drug,” they write.
And the investigators conclude: “Linagliptin may be considered as a safe and effective treatment option, which could improve glycemic control in older patients with [type 2 diabetes] already on treatment with insulin.”
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