Tradjenta Effective Fighting Diabetes for Long-Term: International Study
The drug linagliptin is marketed in U.S. as Tradjenta and as Trajenta in other countries
July 24, 2012 - An extended trial involving older people of a drug for type 2 diabetes has confirmed that the oral DPP-4
inhibitor Tradjenta (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. Linagliptin is marketed in U.S. as Tradjenta, and as Trajenta in other countries.
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.
>> The study participants had an average age of 57.5 years, 75% were younger than 65 years, 51.8% were male and 52.5%
had been diagnosed more than five years ago.
>> The majority had a body mass index of less than 30 kg/m2 (62.4%), a normal or mildly impaired kidney function
(95.6%) and glycated hemoglobin levels of less than 8% (71.2%). The mean baseline glycated haemoglobin and fasting plasma glucose levels were
significantly lower in those subjects who had received linagliptin rather than the placebo in the previous 24-week trials.
>> 1,880 people (88.6%) completed the trial. The main reasons for discontinuing were adverse side effects (3.7%),
refusal to continue medication (2.6%) and lack of therapeutic effect (1.1%).
>> 1,718 subjects (81%) reported at least one adverse episodes during the extension phase. The highest incidence were
in people receiving the combination of linagliptin plus metformin and a sulphonylurea (84.2%), followed by those receiving linagliptin plus
metformin (81.6%). When linagliptin was taken on its own, the adverse side effects rate was lower at 78.8%, similar to those on linagliptin
plus pioglitazone (76%).
>> Most adverse side effects were mild or moderate and the incidence of severe adverse side effects was low at 3.8%,
with 3.4% discontinuing the drug as a result. Overall, 14.3% of participants experienced drug-related adverse incidents.
>> The investigators determined that 13.9% of participants experienced hyploglycaemic (low blood sugar) events and
that about half of these (6.9%) were drug-related.
>> The highest level of drug-related hypoglycaemic events occurred in persons receiving metformin with a
sulophonylurea (11%), with much lower rates for those receiving linagliptin plus metformin (2.1%), lingaliptin on its own (0.5%) and
lingaliptin plus pioglitazone (0.2%).
>> Serious adverse events were reported in 9.9% of the trial subjects, with eight deaths reported during the study
period. However, these were not related to the drug.
>> Long-term lingagliptin use was not associated with a clinically relevant change in body weight, with individuals
previously on the drug losing an average of 0.03kg and those previously on the placebo gaining an average of 0.47 kg.
"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
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.
www.twitter.com/IJCPeditors. It is published by John Wiley & Sons, Inc.
Anyone 45 years old or older should consider getting tested for diabetes. If you are 45 or older and overweight-see the
BMI chart -getting tested is strongly recommended. If you are younger than 45,
overweight, and have one or more of the
risk factors, you should consider getting tested. Ask your doctor for a fasting
blood glucose test or an oral glucose tolerance test. Your doctor will tell you if you have normal blood glucose, prediabetes, or diabetes.
● Among U.S. residents ages 65 years and older, 10.9 million, or 26.9 percent, had diabetes in 2010.
● Diabetes affects 25.8 million people of all ages - 8.3 percent of the U.S. population
> DIAGNOSED - 18.8 million people
●> UNDIAGNOSED - 7.0 million people
● About 215,000 people younger than 20 years had diabetes—type 1 or type 2—in the United States in 2010.
● About 1.9 million people ages 20 years or older were newly diagnosed with diabetes in 2010 in the United States.
● In 2005–2008, based on fasting glucose or hemoglobin A1C (A1C) levels, 35 percent of U.S. adults ages 20 years or
older had prediabetes - 50 percent of adults ages 65 years or older. Applying this percentage to the entire U.S. population in 2010 yields an
estimated 79 million American adults ages 20 years or older with prediabetes.
● Diabetes is the leading cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness
among adults in the United States.
● Diabetes is a major cause of heart disease and stroke.
● Diabetes is the seventh leading cause of death in the United States.