Featured Research

from universities, journals, and other organizations

Type 2 diabetes drug, DPP-4 inhibitor linagliptin, is clinically effective for long-term use, thirty-two country trial suggests

Date:
July 23, 2012
Source:
Wiley
Summary:
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.

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:

  • 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 2 diabetes."


Story Source:

The above story is based on materials provided by Wiley. Note: Materials may be edited for content and length.


Journal Reference:

  1. R. Gomis, D. R. Owens, M.-R. Taskinen, S. Del Prato, S. Patel, A. Pivovarova, A. Schlosser, H.-J. Woerle. 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 extensio. International Journal of Clinical Practice, 2012; 66 (8): 731 DOI: 10.1111/j.1742-1241.2012.02975.x

Cite This Page:

Wiley. "Type 2 diabetes drug, DPP-4 inhibitor linagliptin, is clinically effective for long-term use, thirty-two country trial suggests." ScienceDaily. ScienceDaily, 23 July 2012. <www.sciencedaily.com/releases/2012/07/120723095048.htm>.
Wiley. (2012, July 23). Type 2 diabetes drug, DPP-4 inhibitor linagliptin, is clinically effective for long-term use, thirty-two country trial suggests. ScienceDaily. Retrieved September 2, 2014 from www.sciencedaily.com/releases/2012/07/120723095048.htm
Wiley. "Type 2 diabetes drug, DPP-4 inhibitor linagliptin, is clinically effective for long-term use, thirty-two country trial suggests." ScienceDaily. www.sciencedaily.com/releases/2012/07/120723095048.htm (accessed September 2, 2014).

Share This




More Health & Medicine News

Tuesday, September 2, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Snack Attack: Study Says Action Movies Make You Snack More

Snack Attack: Study Says Action Movies Make You Snack More

Newsy (Sep. 2, 2014) You're more likely to gain weight while watching action flicks than you are watching other types of programming, says a new study published in JAMA. Video provided by Newsy
Powered by NewsLook.com
U.N. Says Ebola Travel Restrictions Will Cause Food Shortage

U.N. Says Ebola Travel Restrictions Will Cause Food Shortage

Newsy (Sep. 2, 2014) The U.N. says the problem is two-fold — quarantine zones and travel restrictions are limiting the movement of both people and food. Video provided by Newsy
Powered by NewsLook.com
Get on Your Bike! London Cycling Popularity Soars Despite Danger

Get on Your Bike! London Cycling Popularity Soars Despite Danger

AFP (Sep. 1, 2014) Wedged between buses, lorries and cars, cycling in London isn't for the faint hearted. Nevertheless the number of people choosing to bike in the British capital has doubled over the past 15 years. Duration: 02:27 Video provided by AFP
Powered by NewsLook.com
Can You Train Your Brain To Eat Healthy?

Can You Train Your Brain To Eat Healthy?

Newsy (Sep. 1, 2014) New research says if you condition yourself to eat healthy foods, eventually you'll crave them instead of junk food. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins