Boehringer Ingelheim and Eli Lilly presented clinical trials results evaluating linagliptin efficacy and safety in Asians with Type 2 Diabetes

2-7-2013 — /europawire.eu/ — New Phase III data presented at the American Diabetes Association 73rd Scientific Sessions® (ADA) showed linagliptin improved blood glucose control as monotherapy and in combination with metformin, in Asian people from China, Malaysia and the Philippines with Type 2 Diabetes.

Ingelheim, Germany and Indianapolis, US, 22 June 2013 – Boehringer Ingelheim and Eli Lilly and Company today presented results from two randomised Phase III clinical trials evaluating the efficacy and safety of linagliptin in Asians from China, Malaysia and the Philippines with Type 2 Diabetes (T2D). The results showed that adults with T2D treated with linagliptin both as monotherapy and in combination with metformin achieved improved blood glucose control compared with placebo.

The rate of Type 2 Diabetes is rapidly increasing in Asia with the present trend indicating that more than 60% of the world’s diabetic population will be in Asia by 2030.¹

“People with Type 2 Diabetes in Asia tend to develop diabetes at a younger age when compared to people in other regions,” said Professor Guang Ning, Director and Professor of the Department of Endocrine and Metabolism, Shanghai Ruijin Hospital, China. “Therefore they tend to suffer longer with the complications of Type 2 Diabetes and have a lower life expectancy compared with people with diabetes from other regions. It is becoming increasingly important to find effective, safe and well tolerated treatments for Asian patients with Type 2 Diabetes. The results of these two trials have shown that linagliptin could become an important option for these patients.”

Results of the first Phase III study, evaluating the efficacy and safety of linagliptin monotherapy in Asians from China, Malaysia and the Philippines with T2D showed that linagliptin demonstrated a 0.68% reduction in HbA1c at 24 weeks versus a reduction of 0.18% in the placebo group (baseline HbA1c 8.09%, p<0.0001). Results for the pre-defined Chinese subgroup were similar to the overall population and the subgroup of patients with baseline HbA1c ≥8.5%, the placebo-corrected decrease in HbA1c from baseline at 24 weeks was −0.91% (P<0.0001).2 HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.³

Results from the second Phase III study evaluating the efficacy and safety of linagliptin added to metformin in Asians from China, Malaysia and The Philippines with T2D found that patients randomised to the linagliptin plus metformin arm achieved a HbA1c reduction of 0.66% versus 0.14% in the placebo group (p<0.0001).

In both studies, linagliptin was well tolerated. In the first study, adverse events (AEs) occurred in 28.0% of linagliptin patients and 28.3% of placebo patients, while drug-related AEs occurred in 3.0% of linagliptin patients and 2.0% of placebo patients. In the second study, AEs occurred in a similar proportion of patients as in the placebo group (27.3% and 28.0%, respectively). Drug-related AEs were reported for 2.4% and 0.0% of linagliptin and placebo patients, respectively. Investigator-defined hypoglycemia occurred in 0.5% and 0.0% of linagliptin and placebo treated patients respectively, in the first study and 1.0% in both groups in the second study. ²,³ The primary endpoint of both studies was change from baseline in mean HbA1c after 24 weeks. ²^,³

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 T2D as monotherapy or in combination with metformin/metformin plus sulphonylurea, and as add-on therapy to insulin. Linagliptin received approval in China in March 2013. With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.^4,5

About the Phase III studies
Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled Type 2 Diabetes mellitus: a 24 week, randomized, Phase III clinical trial: 1218.66
This randomised, Phase III, placebo-controlled, double-blind 24-week study evaluated the efficacy and safety of the DPP-4 inhibitor linagliptin as monotherapy in patients with inadequately controlled T2D in three Asian countries. Patients who were treatment naïve or who had been treated with one antihyperglycemic drug were randomised to either linagliptin 5 mg daily or placebo following 4-week washout of prior drugs. The primary endpoint was change from baseline in mean HbA1c after 24 weeks. The study included a total of 300 Asian patients (China n=261, Malaysia n=22 and the Philippines n=17) with T2D.

Efficacy and safety of linagliptin in Asian patients with Type 2 Diabetes mellitus inadequately controlled on metformin: a 24 week, randomized, Phase III clinical trial: 1218.65
This randomised, Phase III, placebo controlled, double blind 24 week study evaluated the efficacy and safety of linagliptin added to metformin in Asian people with T2D. Antihyperglycemic drugs other than metformin were washed out for 4 weeks prior to randomization to either linagliptin 5mg daily or placebo added to metformin. The primary endpoint of the study was change from baseline in mean HbA1c after 24 weeks.

The study included a total of 306 Asian patients (China n=265, Malaysia n=17 and the Philippines n=24) with T2D.

About Linagliptin
Linagliptin (5 mg, once daily) 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). With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.^4,5 Linagliptin is also approved in combination with metformin in Europe and the US, under the trade name Jentadueto®. Jentadueto® is approved as a twice-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D, who are inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin.

About Diabetes
An estimated 371 million people worldwide have type 1 and T2D.⁶ T2D is the most common type, accounting for an estimated 90% of all diabetes cases.⁷ Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.⁸

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 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.

Boehringer Ingelheim
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 medicine.

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 Euros. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% 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

¹ Ramachandran A, et al. Trends in prevalence of diabetes in Asian countries. World J Diabetes. 2012 June 15; 3(6): 110–117.
² Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled Type 2 Diabetes mellitus: a 24 week, randomized, Phase III clinical trial. Poster No: 1159-P. Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®. June 21-25, Chicago, IL.
³ Efficacy and safety of linagliptin in Asian patients with Type 2 Diabetes mellitus inadequately controlled on metformin: a 24 week, randomized, Phase III clinical trial. Poster No: 1177-P. Presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®. June 21-25, Chicago, IL.
⁴ Jentadueto™ (linagliptin/metformin HCI) tablets. Highlights of Prescribing Information. Initial US Approval: 2012.
⁵ EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011.
⁶ International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
⁷ World 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#
⁸ International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011; (5th Edition).