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
What is the safety and efficacy of linagliptin for the treatment of suboptimally controlled diabetes in elderly subjects?
This was a randomized, double-blind study in 241 patients >70 years of age (mean age, 74.9 years) with type 2 diabetes, glycated hemoglobin (HbA1c) ≥7.0%, receiving metformin, sulfonylureas, insulin, or combinations of these drugs. Subjects received once-daily oral treatment with linagliptin 5 mg or matching placebo for 24 weeks. The primary endpoint was change in HbA1c from baseline to week 24.
At week 24, placebo-adjusted mean change in HbA1c with linagliptin was −0.64% (p < 0.0001). Safety and tolerability were similar between linagliptin and placebo groups, with serious adverse events in 8.6% and 6.3%, respectively.
The authors concluded that linagliptin is a safe and effective glucose-lowering agent in elderly patients.
The elderly represent a large and growing percentage of the population with type 2 diabetes mellitus; however, patients >75 years of age are commonly excluded from clinical trials of glucose-lowering therapies. This is an important group of patients to study, given their comorbidities (including renal impairment, bone loss, and susceptibility to hypoglycemia) and polypharmacy. Dipeptidyl peptidase-4 inhibitors such as linagliptin are generally well tolerated, with little risk of hypoglycemia. Linagliptin, in particular, has minimal drug interactions and is excreted by nonrenal pathways. This drug may therefore be useful for treatment of the elderly population with diabetes mellitus, as this study indicates.
Keywords: Sulfonylurea Compounds, Hemoglobin A, Insulin, Quinazolines, Purines, Metformin, Hypoglycemic Agents, Dipeptidyl-Peptidase IV Inhibitors, Hypoglycemia, Diabetes Mellitus
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