Featured Research

from universities, journals, and other organizations

Type 2 diabetes: Added benefit of linagliptin is not proven, study suggests

Date:
January 6, 2012
Source:
Institute for Quality and Efficiency in Health Care
Summary:
Linagliptin is approved to improve blood glucose control in adults with type 2 diabetes mellitus. As the drug manufacturer chose a different appropriate comparator therapy than specified by the Federal Joint Committee, no proof of an added benefit of linagliptin can be inferred from the manufacturer's dossier.

Linagliptin (trade name: Trajentaฎ) has been approved since August 2011 to improve blood glucose control ("glycaemic control") in adults with type 2 diabetes mellitus whose elevated blood glucose levels are inadequately controlled by diet and exercise. It is an option for patients who do not tolerate or should not take the usual treatment with the drug metformin. Moreover, linagliptin can be added if treatment with metformin alone is not sufficient.

In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether linagliptin offers an added benefit versus the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). No such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the G-BA's specifications and chose a different comparator therapy.

Approval status distinguishes between three treatment situations

The appropriate comparator therapy specified by the G-BA distinguishes between three treatment situations:

  • Administration of linagliptin alone (monotherapy) as a substitute for metformin if this drug is not tolerated by patients or should not be taken because of impaired kidney function. To assess the added benefit, linagliptin monotherapy should be compared with a drug from the sulfonylurea class (glibenclamide or glimepiride).
  • Dual therapy combines linagliptin and metformin and is indicated if treatment with metformin alone is insufficient to control blood glucose levels. To assess the added benefit, dual therapy with linagliptin should be compared with a combination of metformin and a sulfonylurea (glibenclamide or glimepiride).
  • Triple therapy combines linagliptin, metformin and a sulfonylurea and is used if dual therapy with metformin and a sulfonylurea is no longer a sufficient treatment option. To assess the added benefit, triple therapy should be compared with a combination of insulin and metformin.

Drug manufacturer chose a gliptin as comparator therapy

In its dossier, the manufacturer compared linagliptin with a different drug from the gliptin class (sitagliptin) in all three treatment situations and thereby deviated from the specifications of the G-BA. However, in IQWiG's opinion, the manufacturer insufficiently justified this deviation. For the dossier assessment IQWiG therefore uses the appropriate comparator therapy specified by the G-BA.

In the dossier, the manufacturer makes no statements on the extent and probability of an added benefit of linagliptin versus the appropriate comparator therapy specified by the G-BA. Studies that would have been relevant for this purpose were explicitly excluded from the assessment. The manufacturer's dossier therefore provides no proof of an added benefit of linagliptin versus the G-BA's appropriate comparator therapy. This applies to all three treatment situations mentioned above, that is, monotherapy, dual and triple combination therapy.

In the dossier the manufacturer did not determine an added benefit of linagliptin versus the comparator therapy they had chosen themselves (sitagliptin).

G-BA decides on the extent of added benefit

The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, will decide on the extent of added benefit.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Type 2 diabetes: Added benefit of linagliptin is not proven, study suggests." ScienceDaily. ScienceDaily, 6 January 2012. <www.sciencedaily.com/releases/2012/01/120106110544.htm>.
Institute for Quality and Efficiency in Health Care. (2012, January 6). Type 2 diabetes: Added benefit of linagliptin is not proven, study suggests. ScienceDaily. Retrieved October 22, 2014 from www.sciencedaily.com/releases/2012/01/120106110544.htm
Institute for Quality and Efficiency in Health Care. "Type 2 diabetes: Added benefit of linagliptin is not proven, study suggests." ScienceDaily. www.sciencedaily.com/releases/2012/01/120106110544.htm (accessed October 22, 2014).

Share This



More Health & Medicine News

Wednesday, October 22, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Orthodontist Mom Jennifer Salzer on the Best Time for Braces

Orthodontist Mom Jennifer Salzer on the Best Time for Braces

Working Mother (Oct. 22, 2014) — Is your child ready? Video provided by Working Mother
Powered by NewsLook.com
U.S. Issues Ebola Travel Restrictions, Are Visa Bans Next?

U.S. Issues Ebola Travel Restrictions, Are Visa Bans Next?

Newsy (Oct. 22, 2014) — Now that the U.S. is restricting travel from West Africa, some are dropping questions about a travel ban and instead asking about visa bans. Video provided by Newsy
Powered by NewsLook.com
US to Track Everyone Coming from Ebola Nations

US to Track Everyone Coming from Ebola Nations

AP (Oct. 22, 2014) — Stepping up their vigilance against Ebola, federal authorities said Wednesday that everyone traveling into the US from Ebola-stricken nations will be monitored for symptoms for 21 days. (Oct. 22) Video provided by AP
Powered by NewsLook.com
Doctors Help Paralysed Man Walk Again, Patient in Disbelief

Doctors Help Paralysed Man Walk Again, Patient in Disbelief

AFP (Oct. 22, 2014) — Polish doctors describe how they helped a paralysed man walk again, with the patient in disbelief at the return of sensation to his legs. Duration: 1:04 Video provided by AFP
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:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

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