An extended trial of a drug for people with type 2 diabetes has confirmed that the oral DPP-4 inhibitor linagliptin is a safe and effective means of lowering glucose levels for up to 102 weeks, either on its own or in combination with other selected oral anti-diabetic medication.
The 32-country study, published in the August issue of IJCP , the International Journal of Clinical Practice , followed 2,121 individuals who had taken part in four previous 24-week randomised, double-blind, placebo controlled trials, in order to monitor them for a further 78 weeks.
Those subjects who had previously received linagliptin (1,532) continued to do so and those who had received the placebo during the earlier trials (589) were also given the drug during the 78-week trial extension.
The participants who took part in the extended trial came from 231 sites in 32 countries: Argentina, Austria, Belgium, Canada, China, Croatia, the Czech Republic, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, the Philippines, Poland, Romania, Russia, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, the United Kingdom and the United States.
"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 hypoglycaemia (reduced blood sugar levels)" says co-author David R Owens, Professor Emeritus, Centre for Endocrinology and Diabetes Sciences at Cardiff University, Wales, UK.
"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." 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.
Key findings of the extended study included:
"This is the largest data set of long-term clinical evidence for linagliptin to date" concludes Professor Owens.
"Findings from the 78-week open-label extension involving 2,121 people with type 2 diabetes demonstrate sustained glycaemic control for up to 102 weeks treatment duration.
"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."
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Note to editors
Long-term safety and efficacy of linagliptin as monotherapy or in combination with other oral glucose-lowering agents in 2121 subjects with type 2 diabetes: up to 2 years exposure in 24-week phase III trials followed by a 78-week open-label extension. Gomis et al. IJCP . 66.8, pp731. (August 2012). doi: 10.1111/j.1742-1241.2012.02975.x
IJCP , the International Journal of Clinical Practice , was established in 1946 and is edited by Dr Graham Jackson. It provides its global audience of clinicians with high-calibre clinical papers, including original data from clinical investigations, evidence-based analysis and discussions on the latest clinical topics. http://wileyonlinelibrary.com/journal/IJCP , www.twitter.com/IJCPeditors
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International Journal of Clinical Practice