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» Recruitment complete for Trajenta® (linagliptin) cardiovascular outcome study in patients with Type 2 Diabetes
Recruitment complete for Trajenta® (linagliptin) cardiovascular outcome study in patients with Type 2 Diabetes
INGELHEIM, Germany - Thursday, November 8th 2012 [ME NewsWire]
CAROLINA, a head-to-head cardiovascular outcome study comparing Trajenta® (linagliptin)with glimepiride completes recruitment
(BUSINESS WIRE)-- For Non-U.S. and Non-U.K. Media
Boehringer Ingelheim andEli Lilly and Company are pleased to announce that the recruitment of patients for CAROLINA (Cardiovascular Outcome Study of Linagliptin versus Glimepiride in Patients with Type 2 Diabetes)1 has been completed. Linagliptin is currently the only DPP-4 inhibitor that is being compared to an active comparator in a long-termprospective cardiovascular (CV) outcome study.
"CAROLINA has the potential to be a landmark study as it will evaluate cardiovascular safety of linagliptin compared to the sulphonylurea glimepiride. This is the first time a DPP-4 inhibitor is being directly compared to the sulphonylurea class in a long-term cardiovascular outcome study,” said Prof. Julio Rosenstock, Director of the Dallas Diabetes and Endocrine Center, Texas, and Principle Investigator of the study. "Sulphonylureas are the most frequently used add-on therapy to metformin, which is considered the standard first-line therapy. Therefore, the results of CAROLINA could potentially have a significant impact on clinical practice.”
The study includes over 6,000 patients in 43 countries at more than 670 sites across the globe. The aim of the study is to investigate and compare the long-term impact of treatment with linagliptin and glimepiride on CV morbidity and mortality over a period of about 6–7 years.1 In addition, the study will compare secondary measures of efficacy with regard to lowering blood glucose as well as safety parameters, including body weight and the incidence of hypoglycaemia.1 A prior study compared linagliptin with glimepiride with the primary objective to evaluate the respective glucose-lowering efficacy of both compounds after two years of treatment. The study demonstrated similar glucose-lowering with both treatments, but linagliptin was associated with less hypoglycaemia and less weight gain compared to glimepiride. However, this prior study was not designed to thoroughly assess CV effects of both treatments.2
The primary endpoint of CAROLINA will be time to the first occurrence of either: CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for unstable angina pectoris.1 The study is expected to complete in 2018.
"The impact of diabetes treatment options on CV complications is not well understood. This poor understanding poses a challenge for treating physicians given the high level of cardiovascular co-morbidity in Type 2 Diabetes patients,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "CAROLINA will close the scientific gap in our understanding of long-term cardiovascular outcomes with linagliptin and glimepiride. This study illustrates our commitment to provide a strong scientific foundation for the best treatment options.”
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, as add-on therapy to insulin, with sulphonylurea and with pioglitazone and with metformin plus sulphonylurea (these last two combinations have only been approved by the FDA in the United States).3,4 With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment*.3
About CAROLINA Study Design1
CAROLINA evaluates the CV safety of linagliptin in comparison to glimepiride in patients with Type 2 Diabetes and at increased CV risk.
Inclusion criteria include at least one of the following:
Previous vascular complications
Evidence of end organ damage such as albuminuria
Age >70 years
Two or more specified traditional CV risk factors
Patients are predominantly on metformin background therapy, but the protocol also allows for patients with contraindications to metformin, e.g., due to renal impairment. Linagliptin 5 mg is being compared to glimepiride 1–4 mg in 6,000 patients with a 6–7 year follow-up.
*Please also see EU SPC
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2012/08_november_2012_linagliptin.html
Launch and Established Products CVM
Boehringer Ingelheim GmbH
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