NEW YORK — Extended use of the oral DPP-4 inhibitor linagliptin to lower blood-glucose levels by Type 2 diabetes patients is effective, according to a new study.
A team of eight researchers — four of which work for drug maker Boehringer Ingelheim — examined 2,121 Type 2 diabetes patients that had taken part in four previous 24-week randomized, double-blind, placebo-controlled trials in order to monitor them for a further 78 weeks. The participants who took part in the extended trial came from 231 sites in 32 countries.
In an effort to measure the effective of linagliptin as a monotherapy or in combination with other selected oral antidiabetic medications, subjects who had previously received linagliptin (1,532) continued to do so and those who had received the placebo during the earlier trials (589) also were given the drug during the 78-week trial extension. Linagliptin was administered orally once a day in all cases, either on its own, or in combination with metformin or metformin plus a sulphonylurea or pioglitazone.
"Initial 24-week trials showed that linagliptin, either on its own or with other glucose-lowering agents, was effective in improving glycaemic control without weight gain or an independent increased risk of hypoglycemia," said co-author David Owens, professor emeritus and the Centre for Endocrinology and Diabetes Sciences at Cardiff University in Wales. "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."
The researchers found that long-term treatment with linagliptin was well-tolerated with no change in the safety profile observed during the extension study. Those that received linagliptin in the previous studies saw a reduction of 0.8% in their HbA1C levels. Additionally, sustained long-term glycemic control was maintained for up to 102 weeks with either linagliptin monotherapy or linagliptin in combination with other oral glucose-lowering agents. The study findings were published in the International Journal of Clinical Practice.
"Findings from the 78-week open-label extension involving 2,121 people with Type 2 diabetes demonstrate sustained glycemic control for up to 102 weeks treatment duration," Owens said. "They also provide evidence that supports the efficacy and tolerability profile seen in previously reported 24-week studies. Therefore this extension study shows that linagliptin is an effective and well tolerated therapy for the long-term management of Type 2 diabetes."