Table 1 Key inclusion criteria CAROLINA®
Insufficient glycaemic control defined as one of the criteria (A or B) | AND | Elevated risk of cardiovascular events defined as any (one or more) of the criteria (A, B, C or D) |
|---|---|---|
(A) HbA1c 6.5 - 8.5% (48–69 mmol/mol) while patient is treatment naïve or treated with: (I) Metformin monotherapy (II) α-Glucosidase inhibitor monotherapy (e.g. acarbose, voglibose) (III) Metformin plus α-glucosidase inhibitor (e.g. acarbose, voglibose) (B) HbA1c 6.5 - 7.5% (48–58 mmol/mol) while patient is treated with: (I) SU monotherapy (II) Glinide monotherapy (e.g. repaglinide, nateglinide) (III) Metformin plus SU (for a maximum of 5 years) (IV) Metformin plus glinide (for a maximum of 5 years) (V) α-Glucosidase inhibitor plus SU (for a maximum of 5 years) (VI) α-Glucosidase inhibitor plus glinide (for a maximum of 5 years) | (A) Previous vascular disease: (I) MI (>6 weeks prior to informed consent IC) (II) Documented coronary artery disease (⩾50% luminal diameter narrowing of left main coronary artery or in at least two major coronary arteries in angiogram) (III) Percutaneous coronary intervention (>6 weeks prior to IC) (IV) Coronary artery bypass grafting (>4 years prior to IC) or with recurrent angina following surgery (V) Ischaemic or haemorrhagic stroke (>3 months prior to IC) (VI) Peripheral occlusive arterial disease (B) Evidence of vascular-related end-organ damage: (I) Moderately impaired renal function (as defined by MDRD formula) with eGFR 30–59 ml/min/1.73 m2 (II) Random spot urinary albumin:creatinine ratio ⩾30 μg/mg in two of three unrelated specimens in the previous 12 months. (III) Proliferative retinopathy defined as retinal neovascularization or previous retinal laser coagulation therapy (C) Age ≥ 70 years (D) At least two of the following cardiovascular risk factors: (I) T2DM duration >10 years (II) Systolic BP > 140 mmHg (or on at least 1 BP-lowering treatment) <6 months prior to IC (III) Current daily cigarette smoking (IV) LDL-cholesterol ⩾ 135 mg/dL (3.5 mmol/L) (or specific current treatment for this lipid abnormality) <6 months prior to IC | |