CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes | NCT01243424 | Trialant

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes | NCT01243424 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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 International Conference of Harmonisation( ICF)

stable anti-diabetic background for at least 8 wks 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 Investigational Medicinal/Medical Product (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 Transient Ischemic Attack (TIA) =< 3 months prior to ICF