An extended trial of a drug that is commonly used for people who have been diagnosed with type 2 diabetes, an oral DPP-4 inhibitor Linagliptin (Tradjenta) is safe and effective in its ability to lower glucose levels for up to 102 weeks by itself or with a combination of other oral anti-diabetic medication.
The trial consisted of 2,121 people who took part of four recent 24-week randomized, double-blind, and placebo controlled trials and were monitored for 78 weeks more.
During the study, 1,532 people had recently received Linaglipin and continued to do so throughout the study while 589 people received placebo during the 78-week run of the trial.
Participants came from all walks of life, from 231 sites in 32 countries such as 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.
David R Owens, Professor Emeritus, Centre for Endocrinology and Diabetes Sciences at Cardiff University, Wales, UK said, “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 (reduced blood sugar levels). 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 drug was given once daily, orally, in all cases. Many times it was given on its own and other times it was used in a combination of others drugs like metformin or metformin plus a sulphonylurea or pioglitazone.
The study found that the average age among the participants was 57.5 years and 75 percent of the participants where younger than 65. 51.8 percent were male and 52.5 percent were diagnosed more than five years ago.
Some participants has side effects, however they were either mild or moderate. A rare few (3.8 percent) were severe and 3.4 percent has to stop use of the drug altogether. Collectively, 14.3 percent has drug-related adverse effects.
Some participants (13.9 percent) also experienced hypoglycemia (low blood sugar as well and 6.9 percent was related to the drug.
Professor Owens concludes, “This is the largest data set of long-term clinical evidence for linagliptin to date. 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. 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.”