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.

Not Applicable

Conditions: -E11 Non-insulin-dependent diabetes mellitus
Non-insulin-dependent diabetes mellitus
E11

Registration Number: PER-103-10

Lead Sponsor: Boehringer Ingelheim,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 246

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Registration of the following events: cardiovascular death (including fatal stroke and fatal myocardial infarction), nonfatal myocardial infarction, nonfatal stroke and hospitalization for unstable angina pectoris.<br>Measure:Time that elapses until the first event of any of the following awarded components of the combined primary assessment criteria: cardiovascular death (including fatal stroke and fatal myocardial infarction), nonfatal myocardial infarction, nonfatal stroke and hospitalization for unstable angina pectoris<br>Timepoints:During the study<br>

Secondary Outcome Measures

Name	Time	Method

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