A MULTICENTRE, INTERNATIONAL, RANDOMISED, PARALLEL GROUP, DOUBLE BLIND STUDY TO EVALUATE CARDIOVASCULAR SAFETY OF LINAGLIPTIN VERSUS GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AT HIGH CARDIOVASCULAR RISK.

Boehringer Ingelheim,0 个研究点目标入组 246 人开始时间: 2011年1月6日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Type 2 diabetes
•Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
•Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
•BMI =< 45kg/m²
•age between >= 40 and =< 85 years
•signed and dated written ICF
•stable anti-diabetic background for at least 8 weeks before study start

•Type 1 diabetes
•Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
•treatment with any anti-obesity drug less than 3 months before ICF
•uncontrolled hyperglycemia
•previous or planned bariatric surgery or intervention
•current or planned system corticoid treatment
•change in thyroid hormones treatment
•acute liver disease or impaired hepatic function
•pre-planned coronary artery revascularization within 6 months of ICF
•known hypersensitivity to any of the components
•Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
•congestive heart failure class III or IV
•acute or chronic metabolic acidosis
•hereditary galactose intolerance
•alcohol or drug abuse
•participation in another trail with IMP given 2 months before IMP start
•pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
•patients considered reliable by the investigator
•acute coronary syndrome =< 6 wks before ICF
•stroke or TIA =< 3 months prior to ICF

发起方

Boehringer Ingelheim,