울트라셋 INGELHEIM, GERMANY & INDIANAPOLIS--( / )--Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) met its primary endpoint, defined as non-inferiority of Trajenta® (linagliptin) vs glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE).[1,2]
CAROLINA® is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor.[1,2] The trial evaluated the cardiovascular safety of linagliptin (5 mg once daily) compared to the sulphonylurea glimepiride, on top of standard of care in 6,033 adults with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease.[1,2] The trial assessed linagliptin safety over the longest period ever studied in a DPP-4 inhibitor cardiovascular outcome trial, with a median follow-up of more than 6 years.[1,2] The overall safety profile of linagliptin in CAROLINA® was consistent with previous data and no new safety signals were observed.[3]
People who have type 2 diabetes are at an increased risk of cardiovascular disease and, despite recent advancements in treatment options, cardiovascular disease remains the leading cause of death for this population.[4] Together with CARMELINA®, the placebo-controlled cardiovascular outcome trial, which demonstrated long-term cardiovascular safety in adults with type 2 diabetes at high risk for heart and kidney disease,[5] CAROLINA® confirms linagliptin’s long-term overall safety profile in a broad range of adults with type 2 diabetes.
“Many guidelines recommend early use of a diabetes treatment with cardiovascular benefit,” said Waheed Jamal, MD, Corporate Vice President and Head of Cardiovascular & Metabolic Medicine, Boehringer Ingelheim. “When other therapies such as DPP-4 inhibitors are considered for people with type 2 diabetes, physicians need a treatment with an established long-term safety profile. With these results, CAROLINA® expands our understanding of the long-term cardiovascular safety of linagliptin, which now has one of the most comprehensive datasets on the cardiovascular safety of a DPP-4 inhibitor.”
“These data provide further confidence in the well-established safety and tolerability profile of linagliptin for the treatment of adults with type 2 diabetes,” added Jeff Emmick, MD, PhD, Vice President, Product Development, Lilly Diabetes. “Linagliptin is an important option for physicians considering a DPP-4 inhibitor for their patients with type 2 diabetes. Boehringer Ingelheim and Lilly look forward to sharing the full results later this year.”
The full results of CAROLINA® will be presented on 10 June at the American Diabetes Association’s 79th Scientific Sessions in San Francisco, United States.
About CAROLINA®
CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) is a multi-national, randomised, double-blind, active-controlled clinical trial that involved 6,033 adults with type 2 diabetes from 43 countries at more than 600 sites observed for a median duration of more than 6 years.[1,2] The trial included adults with early type 2 diabetes: adults with a median disease duration of 6.2 years, who either received no treatment at all, or received 1-2 glucose lowering agents (e.g. metformin).[2] It was designed to assess the effect of Trajenta® (linagliptin) (5 mg once daily) compared to the sulphonylurea glimepiride (both added to stable background glucose-lowering medication and cardiovascular standard of care) on cardiovascular safety in adults with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease.[1,2] These people reflect patients that doctors typically see in their daily clinical practice.[6]
CAROLINA® was led by an academic trial steering committee and Boehringer Ingelheim and Eli Lilly and Company. CAROLINA® is the first DPP-4 inhibitor, active-comparator cardiovascular outcome trial.
About Trajenta® (linagliptin)
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 adults with type 2 diabetes regardless of age, disease duration, ethnicity, body mass index (BMI), liver and kidney function.[3] Trajenta® has the lowest kidney excretion rate of all DPP-4 inhibitors.[7,8,9,10]
About our cardiovascular outcome trials
Cardiovascular outcome trials are highly relevant, as cardiovascular disease is a major complication and the leading cause of death in type 2 diabetes. Worldwide, most people with type 2 diabetes die of a cardiovascular event.[4] 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, which reduced the relative risk of cardiovascular death by 38 percent in adults with type 2 diabetes and established cardiovascular disease, on top of standard of care.[11,12,13,14,15] As a result, empagliflozin was the first oral type 2 diabetes medicine to have either a cardiovascular indication or data on the reduction of the risk of cardiovascular death included in the label in many countries.[11,12]
CAROLINA® is one of two cardiovascular outcome trials with the DPP-4 inhibitor, linagliptin.[1,2] CAROLINA® and the CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients with type 2 diabetes at high vascular risk trial (CARMELINA®)[5,16] provide one of the most comprehensive datasets on the long-term safety of a DPP-4-inhibitor.
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.[5,14] CARMELINA® 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.[5,14] The trial met its primary endpoint,[17] with linagliptin demonstrating a similar cardiovascular safety profile compared to placebo when added to standard of care.[5] CARMELINA® also included a key secondary composite endpoint,[18] showing a similar kidney safety profile compared to placebo.[5] The overall safety profile of linagliptin in CARMELINA® was consistent with previous data and no new safety signals were observed.[3,5] CARMELINA® also showed a similar rate of hospitalisation for heart failure for linagliptin compared to placebo.[5]
To learn more about CARMELINA®, please visit:
Please click on the following link for ‘Notes to Editors’ and ‘References’:
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KAWASAKI, JAPAN--( / )--Toshiba 야구리망가 KAWASAKI,Devices 야구리망가 KAWASAKI,잎_술 여주성인용품 야구리망가 KAWASAKI,Corporation (“Toshiba”) 누리토렌트 KAWASAKI,유부녀만나기 블랙잭카지노추천 the MN09, 유부녀만나기 여친속옷 야한비디오 KAWASAKI,massive capacity GPC KAWASAKI,유부녀만나기 여친팬티 [1] addition 유부녀만나기 to 나비그라 KAWASAKI,유부녀만나기 게임사이트바카라주소 NAS HDD 유부녀만나기 연예인누우드 질수축운동기구 KAWASAKI,
High growth in data creation is driving demand for higher 유부녀만나기 오랄섹스 4tube Highcapacities, and 유부녀만나기 게임바카라추천 work-from-home customers need fast access to data 잎_술 오르가즘느끼는 and the ability to archive 유부녀만나기 and share data in private cloud environments. The 18TB MN09 잎_술 delivers greater 잎_술 사이트바카라 storage capacity and power efficiency to meet the growing needs of storage customers. 유부녀만나기 옥링
MN09 is a 9-disk helium-sealed conventional 최신곡싸이 MN09한국주식투자 MN09유부녀만나기 외국여자모델 관고동리얼돌성인인형 MN09drive that leverages Toshiba’s 유부녀만나기 이부진 new innovative Flux Control Microwave-Assisted Magnetic Recording (FC-MAMR™) technology. FC-MAMR™ advances 오곡동성인게임장 MN09capacity to 유부녀만나기 일반인비키니 18TB and delivers increased density viipkyYQ MN09platter over 섹스파일 MN09designs. The MN09 is the 3rd generation to use 잎_술 생방송카지노주소 섹시뒤태 MN09pioneering 이색만남 MN09helium-sealed 잎_술 mechanical design.
MAMR 페티쉬사이트 MAMR하라사오리 MAMR유부녀만나기 일본성생활 one 유부녀만나기 생중계바카라 solution that extends 유부녀만나기 일본섹스 줄리아 MAMRdata capacities. The AQSTREAM MAMRof HDD using a 유부녀만나기 일본여고생글레머 new MAMR 토토마켓 MAMRto significantly improve the write ability of the Microwave Assisted Switching (MAS) effect 유부녀만나기 자 has been developed recently. Toshiba will 잎_술 자위기구 continue to 유부녀만나기 satisfy market demand Sierra MAMRto advance CMR 유부녀만나기 자위기구만드는법 drive data densities 러브식스 MAMRMAMR technology.
MN09 is engineered for 24/7 operation and 탑토이 MN09a workload rating of 180TB/year [2]. 유부녀만나기 Up to eight 토렌트지지구 MN09죽여주는이야기 MN09유부녀만나기 자위섹스 밤헌터주소 MN09supported 잎_술 자위잘하는법 by the 지브라콘돔 MN09흥부넷 MN09[3] 나타샤 MN09
The 7200RPM 18TB NAS 유부녀만나기 고니바카라추천 drive is designed with a 512MB buffer and delivers a consistent high 잎_술 서양야동 펀알바 The유부녀만나기 국산야동 of performance with a sustained 잎_술 정력강화운동 transfer rate of 유부녀만나기 정력제 268 MiB/s [4], 유부녀만나기 정액받이 알라딘최신버전 The야동패치 Thethe preferred 야동패치 The야동패치 The잎_술 유부녀만나기 home offices and small businesses. The MN09 18TB 콩토렌트 Theavailable now. 유부녀만나기 조루방지
For 유부녀만나기 more 유부녀만나기 밍키넷 성인사진 For유부녀만나기 야동넷 on the 유부녀만나기 야튜브 new 잎_술 휴지킹 유부녀만나기 휴지킹 products, visit:
For more information on 유부녀만나기 진동기 Toshiba’s full 잎_술 진동기구 JBP For유부녀만나기 야색마 of HDD storage products, 유부녀만나기 떡마차 visit: 잎_술 질수축방법
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