By Sarah Guy
Linagliptin is an effective and well-tolerated therapy for the long-term management of Type 2 diabetes, say the authors of an open-label extension study published in the International Journal of Clinical Practice.
The study findings show that linagliptin, as monotherapy or in combination with other oral glucose-lowering agents, results in sustained lowering of glycated hemoglobin (HbA1c) levels, and a low rate of drug-related adverse events.
"Linagliptin works by blocking the action of DPP-4, an enzyme that destroys the hormone GLP-1, which helps the body produce more insulin when it is needed," explained David Owens (Cardiff University, UK) in a statement to the press.
Participants of the study (n=1880) had all taken part in at least one of four 24-week parent randomized, placebo-controlled trials involving linagliptin, and those who were assigned to take placebo received linagliptin during the current extension study.
The cohort was aged a mean 57.5 years. After an average 515 days exposure to linagliptin, or linagliptin in addition to metformin background therapy, metformin, and a sulfonylurea background therapy, or pioglitazone as initial combination treatment, just 14.3% experienced drug-related adverse events, the most common of which was hypoglycemia, at 6.9%.
The researchers found that participants who received linagliptin monotherapy and linagliptin with pioglitazone reported the lowest frequency of hypoglycemic events, at 0.5% and 0.2%, respectively. And while eight deaths were reported during the study, none were considered by Owens and colleagues to be related to the study drugs.
The findings also confirm the glucose-lowering effect of linagliptin seen in the parent trials, remark the authors. Specifically, the 0.8% reduction in HbA1c levels seen during the parent trials among participants who received linagliptin, alone or in any combination, was sustained through the extension trial.
Furthermore, participants previously assigned to placebo who received linagliptin in the extension study achieved a mean 0.9% decrease over the 78 weeks, the authors note.
"This is the largest data set of long-term clinical evidence for linagliptin to date," said Owens. "For the long-term management of Type 2 diabetes, linagliptin is an effective and well-tolerated therapy," he and his co-authors conclude.
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