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Linagliptin appears effective in type 2 diabetes after 78 weeks
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A study involving patients with type 2 diabetes in 32 countries demonstrates that the DPP-IV inhibitor linagliptin — either alone or combined with another oral antidiabetic agent — was safe and effective at lowering glucose for up to 102 weeks. The study is published in the International Journal of Clinical Practice.
More than 2,000 patients (n=2,121) who had participated in four previous 24-week randomized, double blind, placebo-controlled trials were monitored for 78 weeks. The 1,532 patients who had previously received linagliptin (Tradjenta, Boehringer Ingelheim) and the 589 patients who had previously received placebo were given linagliptin during the 78-week extension.
“Initial 24-week trials showed that linagliptin, either on its own or with other glucose-lowering agents, was effective in improving glycemic control without weight gain or an independent increased risk of hypoglycemia,” David R. Owens, professor emeritus at the Center for Endocrinology and Diabetes Sciences at Cardiff University in Wales, United Kingdom, said in a press release.
The mean age of the patients included in the study was 57.5 years; 51.8% were male and 52.5% had been diagnosed with type 2 diabetes more than 5 years ago. BMI for most of the participants was less than 30, and most had normal or mildly impaired kidney function and HbA1c levels of less than 8%. More than 85% of participants completed the trial (n=1,880). Those who received linagliptin had significantly lower baseline HbA1c and fasting plasma glucose levels vs. those who received placebo during the 24-week trials.
During the extension phase, 81% of participants reported at least one adverse event, with the highest incidence occurring in those who received linagliptin plus metformin and a sulphonylurea (84.2%) and those who received linagliptin plus metformin (81.6%). The rate of adverse events among those who received linagliptin alone was 78.8%, and 76% among those who received linagliptin plus pioglitazone.
Hypoglycemia occurred among 13.9% of participants, and 6.9% events were drug-related.
Patients receiving metformin plus a sulphonylurea experienced the highest level of drug-related hypoglycemia (11%), followed by those receiving linagliptin plus metformin (2.1%), linagliptin alone (0.5%) and linagliptin plus pioglitazone (0.2%).
Eight deaths occurred, although none were related to the study drug.
“[Findings] … provide evidence that supports the efficacy and tolerability profile seen in previously reported 24-week studies,” Owens said. “Therefore, this extension study shows that linagliptin is an effective and well-tolerated therapy for the long-term management of type 2 diabetes.”
Disclosure: Four researchers are employees of Boehringer Ingelheim.
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