Data presented at the American Diabetes Association 73rd Scientific
Sessions® also show statistically significant reductions in mean daily glucose
and body weight in people with type 2 diabetes
BURLINGTON AND TORONTO, ON, June 22, 2013 /CNW/ - Boehringer Ingelheim
and Eli Lilly and Company today announced results of two Phase III
24-week clinical trials of the investigational agent empagliflozin1 added to metformin with and without the addition of sulphonylurea, in
people with type 2 diabetes mellitus (T2DM). The results showed
statistically significant improvements in blood glucose as measured by
reductions in HbA1c (average blood glucose) after 24 weeks among people
who received empagliflozin.1,2
Empagliflozin is a member of the sodium glucose co-transporter 2
(SGLT2) inhibitor class of compounds, and is being investigated for the
reduction of blood glucose levels in adults with T2DM. The emerging
SGLT2 inhibitor class removes excess glucose through the urine by
blocking glucose reabsorption by the kidney.
The study, presented at the American Diabetes Association (ADA) 73rd
Scientific Sessions®, also demonstrated statistically significant reductions in key
secondary endpoints, including mean daily glucose concentration and
body weight.1,2 Overall, adverse events were reported in a similar percentage of
patients treated with empagliflozin 10mg, empagliflozin 25mg and
"Physicians will welcome the availability of another agent in the fight
against type 2 diabetes that can be added-on to metformin or metformin
plus sulphonylurea," said Dr. Stewart Harris, CDA Chair in Diabetes
Management and the Ian McWhinney Chair of Family Medicine Studies at
Western University. "This new treatment regimen has the potential to
demonstrate a significant reduction of blood glucose levels and also
offer weight loss, something that will be encouraging to patients."
24-week study with empagliflozin as an add-on to metformin
In this 24-week randomised, double-blind, placebo-controlled trial, the
addition of empagliflozin to a background of metformin showed a
placebo-adjusted reduction in HbA1c of 0.57 per cent and 0.64 per cent
(p<0.001) for empagliflozin 10mg (n=217) and 25mg (n=213),
respectively, compared with placebo (n=207).1 The study also showed a statistically significant placebo-adjusted
reduction at 24 weeks in mean daily glucose concentration of 0.42mmol/L
with empagliflozin 10mg (p=0.006) and 0.69mmol/L with empagliflozin
25mg (p<0.001).1 Body weight also significantly decreased by 1.63kg and 2.01kg (p<0.001)
with the addition of empagliflozin 10mg and 25mg, respectively,
compared with metformin.1
Drug-related adverse events were reported by 16.1 per cent, 12.6 per
cent, and 12.1 per cent of patients on empagliflozin 10mg,
empagliflozin 25mg, and placebo, respectively. Confirmed hypoglycemia
was reported in 1.8 per cent of patients on empagliflozin 10mg, 1.4 per
cent on empagliflozin 25mg and 0.5 per cent on placebo, none of which
required assistance. Adverse events consistent with urinary tract
infection were reported in 5.1 per cent of patients on empagliflozin
10mg, 5.6 per cent on empagliflozin 25mg and 4.9 per cent on placebo.
Adverse events consistent with genital infection were reported in 3.7
per cent of patients on empagliflozin 10mg, 4.7 per cent on
empagliflozin 25mg and 0.0 per cent on placebo.
24-week study with empagliflozin as an add-on to metformin and
In this 24-week randomised, double-blind, placebo-controlled trial, the
addition of empagliflozin to a background of metformin plus
sulphonylurea therapy showed a placebo-adjusted reduction in HbA1c of
0.64 per cent and 0.59 per cent (p<0.001) for empagliflozin 10mg
(n=225) and 25mg (n=216), respectively, compared with placebo (n=225).2 The study also showed a statistically significant placebo-adjusted
reduction at 24 weeks in mean daily glucose concentration of 0.56mmol/L
and 0.72mmol/L (p<0.001) with empagliflozin 10mg and 25mg,
respectively.2 Reductions in body weight were significantly greater with the addition
of empagliflozin to metformin plus sulphonylurea (change in body weight
of 1.75 kg, 10mg; and 1.99 kg, 25mg; p<0.001). 2
Drug-related adverse events were reported by 24.1 per cent, 19.8 per
cent and 15.5 per cent of patients on empagliflozin 10mg, empagliflozin
25mg and placebo, respectively. Confirmed hypoglycaemia was reported in
16.1 per cent of patients on empagliflozin 10mg, 11.5 per cent on
empagliflozin 25mg and 8.4 per cent on placebo; none of which required
assistance. Adverse events consistent with urinary tract infection were
reported in 10.3 per cent of patients on empagliflozin 10mg, 8.3 per
cent on empagliflozin 25mg and 8.0 per cent on placebo. Adverse events
consistent with genital infection were reported in 2.7 per cent of
patients on empagliflozin 10mg, 2.3 per cent on empagliflozin 25mg and
0.9 per cent on placebo.
About the empagliflozin phase III clinical trial program
Empagliflozin is being investigated in adults with T2DM in a Phase III
clinical trial program that plans to enrol more than 14,500 patients.
This program comprises more than 10 multinational clinical trials,
including a large cardiovascular outcomes trial.
An estimated 371 million people worldwide3 have type 1 or type 2 diabetes. Type 2 diabetes is the most common
type, accounting for an estimated 90 per cent of all diabetes cases.4 Diabetes is a chronic condition that occurs when the body either does
not properly produce, or use, the hormone insulin.5 Today, more than 9 million Canadians live with diabetes or prediabetes
- a condition that, if left unchecked increases the risk of developing
type 2 diabetes.6
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three
compounds representing several of the largest diabetes treatment
classes. This alliance leverages the companies' strengths as two of the
world's leading pharmaceutical companies, combining Boehringer
Ingelheim's solid track record of research-driven innovation and
Lilly's innovative research, experience and pioneering history in
diabetes. By joining forces, the companies demonstrate commitment in
the care of patients with diabetes and stand together to focus on
patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.
About Boehringer Ingelheim (Canada) Ltd.
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 140 affiliates and more than 46,000 employees.
Since it was founded in 1885, the family-owned company has been
committed to researching, developing, manufacturing and marketing novel
medications of high therapeutic value for human and veterinary
Social responsibility is a central element of Boehringer Ingelheim's
culture. Involvement in social projects, caring for employees and their
families, and providing equal opportunities for all employees form the
foundation of the global operations. Mutual cooperation and respect, as
well as environmental protection and sustainability are intrinsic
factors in all of Boehringer Ingelheim's endeavors.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion
euro. R&D expenditure in its Prescription Medicines business
corresponds to 22.5 per cent of its net sales.
The Canadian headquarters of Boehringer Ingelheim was established in
1972 in Montreal, Quebec and is now located in Burlington, Ontario.
Boehringer Ingelheim employs more than 550 people across Canada.
For more information please visit www.boehringer-ingelheim.ca.
About Eli Lilly Canada Inc.
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products
by applying the latest research from its own worldwide laboratories and
from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Indiana, Lilly provides answers -
through medicines and information - for some of the world's most urgent
medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario,
employs close to 500 people across the country. Additional information
about Eli Lilly Canada can be found at www.lilly.ca.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we
introduced the world's first commercial insulin. Today we work to meet
the diverse needs of people with diabetes through research and
collaboration, a broad and growing product portfolio and a continued
commitment to providing real solutions - from medicines to support
programmes and more - to make lives better.
For more information, visit www.lillydiabetes.com.
*Empagliflozin is an investigational compound. Its safety and efficacy
have not yet been fully established and is not currently authorized for
sale in Canada.
1 Häring H et al, Empagliflozin as Add-On to Metformin for 24 Weeks
Improves Glycemic Control in Patients with Type 2 diabetes (T2DM).
Poster No: 1092-P. Presented at the American Diabetes Association®
(ADA) 73rd Scientific Sessions. June 21-25, Chicago, IL.
2 Häring H et al, Empagliflozin as Add-On to Metformin Plus Sulfonylurea
(SU) for 24 Weeks Improves Glycemic Control in Patients with Type 2
diabetes (T2DM). Poster No: 1082-P. Presented at the American Diabetes
Association® (ADA) 73rd Scientific Sessions. June 21-25, Chicago, IL.
3 International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact
4 Canadian Diabetes Association. Diabetes facts. Available at http://www.diabetes.ca/diabetes-and-you/what/facts/ Accessed on May 24, 2013
5 International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What
is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: April 4, 2013
6 Canadian Diabetes Association. The Harsh Reality. Available at http://www.diabetes.ca/diabetes-and-you/living/harsh-reality/ Accessed on: May 24, 2013
SOURCE: Boehringer Ingelheim
For further information:
Brand Communication Associate
Boehringer Ingelheim (Canada) Ltd.
Phone: (905) 631-4739
Eli Lilly Canada Inc.
Phone: (416) 693-3169