INGELHEIM, Germany & INDIANAPOLIS, US–(BUSINESS WIRE)–Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today presented the full results of the long-term cardiovascular outcome trial, CARMELINA®, which studied the impact of Trajenta® (linagliptin) on cardiovascular and kidney safety in adults with type 2 diabetes at high risk for heart and/or kidney disease.1,2 The study met its primary endpoint,* with linagliptin demonstrating a similar cardiovascular safety profile compared to placebo when added to standard of care.1 CARMELINA® also included a key secondary composite endpoint,† showing a similar kidney safety profile compared to placebo.1
The overall safety profile of linagliptin in CARMELINA® was consistent with previous data and no new safety signals were observed.1 CARMELINA® also showed a similar rate of hospitalisation for heart failure for linagliptin compared to placebo.1
The full results were presented at the 54th European Association for the Study of Diabetes (EASD) Annual Meeting in Berlin, Germany.
“Heart disease is a major complication and the leading cause of death for people living with type 2 diabetes. CARMELINA® adds important new evidence for type 2 diabetes patients at high risk of heart and/or kidney disease, a population that has been underrepresented in other cardiovascular outcome trials, but whom we see in our daily practice. The trial confirmed that linagliptin can be used with confidence in this patient population,” commented Bernard Zinman, M.D., Professor in the Department of Medicine, University of Toronto and Senior Scientist at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada.
In CARMELINA®, cardiovascular events that contributed to the primary endpoint* occurred in 12.4 percent (434 people) of the linagliptin group compared to 12.1 percent (420 people) in the placebo group, demonstrating a similar long-term cardiovascular safety profile in adults with type 2 diabetes.1 Linagliptin also showed a similar long-term kidney safety profile compared to placebo. This was demonstrated on the composite endpoint reflecting declining kidney function† occurring in 9.4 percent (327 people) of the linagliptin group compared to 8.8 percent (306 people) of the placebo group.1
An increase in the risk of hospitalisation for heart failure has been observed in some other cardiovascular outcome trials in diabetes.3,4 In CARMELINA®, this endpoint was pre-specified and assessed thoroughly via adjudication.‡ Hospitalisation for heart failure occurred in 6 percent (209 people) of the linagliptin group compared to 6.5 percent (226) of the placebo group.1 “These results are particularly meaningful given the patient population in CARMELINA, including those most vulnerable to developing heart failure,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
“While many guidelines5,6 now recognise the importance of choosing a diabetes treatment with a proven benefit on reducing cardiovascular risk and mortality in people with type 2 diabetes and heart disease, there remains a need for additional glucose-lowering options,” Waheed Jamal pointed out. “CARMELINA® reinforces confidence in linagliptin as an effective and well-tolerated treatment, with a simple dosing regimen for adults with type 2 diabetes.”
“We have created a unique cardiovascular outcome trial programme for linagliptin with two trials — CARMELINA®, whose results are released today, as well as CAROLINA®, which will report initial results in the near future,” added Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly Diabetes. “This programme will provide clinical data on the long-term safety profile of linagliptin in a broad range of adults with type 2 diabetes, which reflects patients that doctors see in their daily practice.7”
CARMELINA® is a multi-national, randomised, double-blind, placebo-controlled clinical trial that involved 6,979 adults with type 2 diabetes from 27 countries at more than 600 sites observed for a median duration of 2.2 years.2,8 The study was designed to assess the effect of linagliptin (5mg once daily) compared to placebo (both added to standard of care) on cardiovascular outcomes in adults with type 2 diabetes and high cardiovascular risk, the majority of whom also had kidney disease.2,8 This population of people with high risk of cardiovascular and/or kidney disease reflects patients that doctors see in their daily practice.7 Standard of care included both glucose lowering agents and cardiovascular drugs (including antihypertensive and lipid lowering agents).
CARMELINA® was led by an academic trial steering committee and the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance. Compared to other recently reported outcome trials of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes, CARMELINA® included the highest number of patients with impaired kidney function.§
To learn more about CARMELINA®, please visit: https://www.carmelinatrial.com/
Trajenta® is a one dose, once daily DPP-4 inhibitor that provides significant efficacy in the reduction of blood sugar levels for adults with type 2 diabetes. It can be prescribed for adult patients with type 2 diabetes regardless of age, disease duration, ethnicity, body mass index (BMI), liver and kidney function.9 Trajenta® has the lowest kidney excretion rate of all DPP-4 inhibitors.9-13
About our cardiovascular outcome trials
As cardiovascular disease is a major complication and the leading cause of death in type 2 diabetes,14 cardiovascular safety of all type 2 diabetes treatments is important. Worldwide, most people with type 2 diabetes die of a cardiovascular event.15 In 2015, Boehringer Ingelheim and Eli Lilly and Company announced results from the landmark cardiovascular outcome trial EMPA-REG OUTCOME® with the SGLT2 inhibitor empagliflozin.16,17
CARMELINA® is one of two cardiovascular outcome trials with the DPP-4 inhibitor linagliptin. CAROLINA®,18 will be the first DPP-4 inhibitor cardiovascular outcome trial to compare commonly used second line treatments — linagliptin and the sulphonylurea glimepiride. This trial includes adults with relatively early type 2 diabetes and increased cardiovascular risk or established complications, with less than optimised blood sugar control. The majority did not yet have heart and kidney disease. The study will report initial results in the near future. CARMELINA® and CAROLINA® will provide clinical data on the long-term safety profile of linagliptin in a broad range of adults with type 2 diabetes, which reflects patients that doctors see in their daily practice.7
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/CARMELINA
* Primary endpoint defined as time to first occurrence of the 3-P MACE (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke)
† Key secondary endpoint defined as time to first occurrence of sustained end stage kidney disease (ESKD), death due to kidney disease, or a sustained decrease in eGFR from baseline of ≥40 percent compared to placebo
‡ Assessed by an independent clinical event committee in a blinded way
§ Glomerular filtration rate below 30 mL/min/m2
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