INGELHEIM, Germany I March 19, 2013 I Boehringer Ingelheim and Eli Lilly and Company announced today the initiation of a Phase IIIb trial to evaluate the glycaemic efficacy and safety of linagliptin in type 2 diabetes patients with prevalent albuminuria, and urinary albumin-to-creatinine (UACR) ratio 30-3000 mg/g creatinine, in addition to current standard therapy for diabetic nephropathy. The name of the clinical trial is MARLINA™*.
"With linagliptin, no dose adjustment is required even for patients with declining renal function", said Professor Per-Henrik Groop, Professor of Nephrology, and Chief Physician at the Division of Nephrology, Helsinki University Central Hospital, Helsinki, Finland and Principal Investigator of the MARLINA™ trial. "What is of particular interest is that this study will evaluate the glycaemic efficacy and safety of linagliptin therapy in patients with type 2 diabetes whose kidneys are excreting significant amounts of albumin, a marker of both, kidney damage as well as an overall increased cardiovascular risk."
The primary endpoint of MARLINA™ is the change from baseline in HbA1c after 24 weeks of treatment. The study is expected to complete in 2014.
"The initiation of this new trial reinforces our ongoing commitment to the field of type 2 diabetes" said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "It is important to find more treatment options, especially for those patients who are at risk of renal and cardiovascular disease and who have limited choices of treatment".
The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory authorities worldwide approved linagliptin for the treatment of adult patients with Type 2 Diabetes as monotherapy or in combination with metformin, metformin plus sulphonylurea, and as add-on therapy to insulin. In the US, linagliptin is also approved for use in this population with sulphonylurea and with pioglitazone.1 With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.1,2
About MARLINA™ Study Design
MARLINA™ is a Phase IIIb, multicentre, multinational, randomised, double-blind, placebo controlled, parallel group study to evaluate the glycaemic efficacy of once daily administration of linagliptin (5 mg for 24 weeks) in type 2 diabetes patients, with micro- or macroalbuminuria (30-3000mg/g creatinine) in addition to current standard treatment for diabetic nephropathy (ACEi or ARB).
About Linagliptin
Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin) tablets, as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with type 2 diabetes. 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). With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.1,2
About Diabetes
An estimated 371 million people worldwide have type 1 and type 2 diabetes.3 Type 2 diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.4 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.5
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 centers on three pipeline compounds representing several of the largest 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
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 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 medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act with social responsibility. 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 endeavours.
In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales. For more information please visit www.boehringer-ingelheim.com
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
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 programs and more – to make lives better.
For more information, visit www.lillydiabetes.com
This press release contains forward-looking statements about linagliptin tablets for the treatment of type 2 diabetes. It reflects Lilly’s current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that linagliptin will prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
References
1Jentadueto® (linagliptin/metformin HCI) tablets. Highlights of Prescribing Information. Initial US Approval: 2012.
2EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011.
3International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
4World Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html#
5International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011; (5th Edition).
*MARLINA™ (efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin).
SOURCE: Boehringer Ingelheim
Post Views: 299
INGELHEIM, Germany I March 19, 2013 I Boehringer Ingelheim and Eli Lilly and Company announced today the initiation of a Phase IIIb trial to evaluate the glycaemic efficacy and safety of linagliptin in type 2 diabetes patients with prevalent albuminuria, and urinary albumin-to-creatinine (UACR) ratio 30-3000 mg/g creatinine, in addition to current standard therapy for diabetic nephropathy. The name of the clinical trial is MARLINA™*.
"With linagliptin, no dose adjustment is required even for patients with declining renal function", said Professor Per-Henrik Groop, Professor of Nephrology, and Chief Physician at the Division of Nephrology, Helsinki University Central Hospital, Helsinki, Finland and Principal Investigator of the MARLINA™ trial. "What is of particular interest is that this study will evaluate the glycaemic efficacy and safety of linagliptin therapy in patients with type 2 diabetes whose kidneys are excreting significant amounts of albumin, a marker of both, kidney damage as well as an overall increased cardiovascular risk."
The primary endpoint of MARLINA™ is the change from baseline in HbA1c after 24 weeks of treatment. The study is expected to complete in 2014.
"The initiation of this new trial reinforces our ongoing commitment to the field of type 2 diabetes" said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "It is important to find more treatment options, especially for those patients who are at risk of renal and cardiovascular disease and who have limited choices of treatment".
The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory authorities worldwide approved linagliptin for the treatment of adult patients with Type 2 Diabetes as monotherapy or in combination with metformin, metformin plus sulphonylurea, and as add-on therapy to insulin. In the US, linagliptin is also approved for use in this population with sulphonylurea and with pioglitazone.1 With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.1,2
About MARLINA™ Study Design
MARLINA™ is a Phase IIIb, multicentre, multinational, randomised, double-blind, placebo controlled, parallel group study to evaluate the glycaemic efficacy of once daily administration of linagliptin (5 mg for 24 weeks) in type 2 diabetes patients, with micro- or macroalbuminuria (30-3000mg/g creatinine) in addition to current standard treatment for diabetic nephropathy (ACEi or ARB).
About Linagliptin
Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin) tablets, as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with type 2 diabetes. 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). With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.1,2
About Diabetes
An estimated 371 million people worldwide have type 1 and type 2 diabetes.3 Type 2 diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.4 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.5
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 centers on three pipeline compounds representing several of the largest 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
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 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 medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act with social responsibility. 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 endeavours.
In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales. For more information please visit www.boehringer-ingelheim.com
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, IN, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
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 programs and more – to make lives better.
For more information, visit www.lillydiabetes.com
This press release contains forward-looking statements about linagliptin tablets for the treatment of type 2 diabetes. It reflects Lilly’s current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialisation. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that linagliptin will prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
References
1Jentadueto® (linagliptin/metformin HCI) tablets. Highlights of Prescribing Information. Initial US Approval: 2012.
2EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011.
3International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
4World Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html#
5International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011; (5th Edition).
*MARLINA™ (efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin).
SOURCE: Boehringer Ingelheim
Post Views: 299
