Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
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The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with T2DM and to compare outcomes against placebo, on a background of standard of care.
CARMELINA: A Multicenter, International, Randomized, Parallel Group, Double-blind, Placebo-controlled, Cardiovascular Safety and Renal Microvascular Outcome Study With Linagliptin, 5 mg Once Daily in Patients With Type 2 Diabetes Mellitus at High Vascular Risk
Actual Study Start Date :
July 10, 2013
Actual Primary Completion Date :
January 18, 2018
Actual Study Completion Date :
January 18, 2018
Resource links provided by the National Library of Medicine
Time to the first occurrence of any of the following by adjudication confirmed components of the primary composite endpoint (3-point MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: 54 months ]
Secondary Outcome Measures :
Time to the first occurrence of any of the following by adjudication confirmed components: Composite renal endpoint (renal death, sustained end stage renal disease, sustained decrease of 40% or more in estimated glomerular filtration rate) [ Time Frame: 54 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Documented diagnosis of T2DM before visit 1(screening).
Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with GLP-1 receptor agonists, DPP-4 inhibitors or SGLT-2 inhibitors if => consecutive 7 days.
Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than 10% within the 8 weeks prior to randomization compared with the daily insulin dose at randomization.
HbA1c of => 6.5% and <= 10.0% at Visit 1 (screening)
Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1
Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening)
Signed and dated written informed consent by date of Visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure
High risk of CV events defined by: 1) albuminuria (micro or macro) and previous macrovascular disease and/or 2) impaired renal function with predefined UACR
Type 1 diabetes mellitus.
Treatment (=> 7 consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials where these antidiabetic drugs have been provided to the patient.
Active liver disease or impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1.
eGFR <15 ml/min/1.73 m2 (severe renal impairment or ESRD, MDRD formula), as determined during screening at Visit 1 and/or the need for maintenance dialysis.
Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic) or intervention (gastric sleeve).
Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent.
Known hypersensitivity or allergy to the investigational products or its excipients.
Any previous or current alcohol or drug abuse that would interfere with trial participation in the opinion of the investigator.
Participation in another trial with an investigational drug ongoing or within 2 months prior to visit 1 (screening).
Pre-menopausal women (last menstruation = 1 year prior to informed consent) who are nursing or pregnant, are of child-bearing potential and are not practicing an acceptable method of birth control (acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local authorities), double barrier method and vasectomised partner) or do not plan to continue using acceptable method of birth control throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Patients considered unreliable by the investigator concerning the requirements for follow up during the study and/or compliance with study drug administration, have a life expectancy less than 5 years for non-CV causes, or have cancer other than non-melanomaskin cancer within last 3 years, or has any other condition than mentioned which in the opinion of the investigator, would not allow safe participation in the study.