INGELHEIM, Germany and INDIANAPOLIS, US - Tuesday, September 24th 2013 [ME NewsWire]
Pooled analysis of trial data showed linagliptin was well tolerated
including in the elderly with normal renal function to severe renal
impairment
The overall incidence of adverse events was similar for linagliptin compared to placebo
(BUSINESS WIRE)-- For Non-US and Non-UK Media
Poster No. 926 & 986
Boehringer
Ingelheim and Eli Lilly and Company today announced that results from
two different pooled analyses of clinical studies support previous
observations that the dipeptidyl peptidase-4 (DPP-4) inhibitor
linagliptin was shown to be well tolerated in a broad range of adults
with Type 2 Diabetes (T2D). These data were presented at the 49th
European Association of Diabetes (EASD) Annual Meeting.
General safety analysis
Findings
from a pooled comprehensive analysis of safety data in 22 linagliptin
clinical trials with 7,400 people with T2D (4,810 received linagliptin,
2,590 received placebo) included the following:1
Linagliptin was well tolerated overall and across all age groups studied, with a low incidence of hypoglycemic events
In an exploratory analysis, overall hypoglycaemia was lower for
linagliptin compared to placebo (11.5 percent versus 14 percent,
p=0.0021)
Overall incidence of adverse events (AE) or serious
adverse events (SAE) with linagliptin was similar to placebo (AE 56.5
percent versus 61.2 percent, and SAE 4.8 percent versus 6.3 percent,
respectively)
The incidence of AEs with linagliptin compared to
placebo remained similar irrespective of the age category (≤65 years,
65-74 years, ≥75 years)
“Drug tolerability is an important
consideration in the selection of appropriate treatments for people with
Type 2 Diabetes, as often different populations will have drug
contra-indications and require dose adjustments to manage their
disease,” said Prof. Nikolaus Marx, Professor of Medicine and
Cardiology, University Hospital of Aachen, Germany. “The results
presented today support the safety profile of linagliptin.”
Renal safety in the elderly
Results
from a post-hoc analysis of pooled data from seven clinical trials
including 1,293 people with T2D aged 65 years or older showed:2
Linagliptin was well tolerated providing clinical efficacy in an
elderly population with renal function ranging from normal to severe
renal impairment
Overall renal function was not significantly altered by treatment with linagliptin from baseline to week 24, versus placebo
Patients taking linagliptin achieved a HbA1c reduction of -0.6 percent
from baseline and −0.8 mmol/L for fasting plasma glucose (both values
placebo-corrected)
The overall incidence of AEs with linagliptin was similar to placebo (71.3 percent versus 72.8 percent, respectively)
Incidence of investigator-defined hypoglycaemia was not higher in
patients who received linagliptin compared to those receiving placebo
(21.3 percent versus 24.7 percent), with most events occurring in the
trials that included a sulphonylurea or basal insulin as background
therapy
Renal and urinary AEs were experienced by 5.5 percent and 4.3 percent of linagliptin and placebo patients, respectively
“The
data presented from these analyses supplement the already established
evidence demonstrating that linagliptin is a well-tolerated treatment
for a broad range of people with Type 2 Diabetes,” said Professor Klaus
Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.
“This should provide physicians further assurance when treating
different patient types with linagliptin.”
The U.S. Food and Drug
Administration (FDA), European Medicines Agency (EMA) and several other
regulatory authorities worldwide have approved linagliptin for the
treatment of adults with T2D as monotherapy or in combination with
metformin, metformin + sulphonylurea, and as add-on therapy to insulin.
With linagliptin, no dose adjustment is required regardless of renal
function or hepatic impairment.3,4
About Linagliptin
Linagliptin
(5 mg) is marketed in Europe as Trajenta® (linagliptin) and in the U.S.
as Tradjenta® (linagliptin), as a once-daily tablet that is used along
with diet and exercise to improve glycaemic control in adults with T2D.
Linagliptin should not be used in patients with Type 1 Diabetes or for
the treatment of diabetic ketoacidosis (increased ketones in the blood
or urine).3,4
Please click on the link below for ‘Notes to Editors’ and ‘References’
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/24_september_2013linagliptin.html
Contacts
Boehringer Ingelheim GmbH
Dr. Petra Kienle
Launch and Established Products CVM
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77-143877
Lilly Diabetes
Tammy Hull
Communications Manager
Email: hullta@lilly.com
Phone: +1 (317) 651 9116
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