Clinical trial NCT00145925 (phase 3, status: completed)
Conditions: diabetes mellitus, type 2
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: perindopril-indapamide, gliclazide mr-based glucose lowering
SMILES: CC1=CC=C(C=C1)S(=O)(=O)NC(=O)NN1CC2CCCC2C1
Eligibility criteria:

        Inclusion Criteria:

          1. A diagnosis of type 2 diabetes mellitus first made at age 30 years or older

          2. Age 55 years or older at entry

          3. Ability to provide informed consent

          4. A substantially elevated risk of cardiovascular disease, indicated by:

               -  A history of major macrovascular disease defined as any one of: stroke,
                  myocardial infarction, hospital admission for transient ischaemic attack,
                  hospital admission for unstable angina, coronary artery bypass graft,
                  percutaneous transluminal coronary angioplasty (with or without stenting),
                  peripheral revascularisation (angioplasty or surgery) or amputation secondary to
                  vascular disease or

               -  A history of major microvascular disease defined as any one of nephropathy
                  (albumin:creatinine ratio >300ug/mg), retinal photocoagulation therapy,
                  proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous
                  haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or
                  elsewhere), macular oedema (retinal thickening within one disc diameter of the
                  macular centre) or blindness in either eye (corrected visual acuity 6/60 or
                  worse, persisting for three months or more) not known to be due to non-diabetic
                  causes or

               -  A first diagnosis of type 2 diabetes made 10 or more years prior to entry or

               -  Another major risk factor for vascular disease defined as any one of: current
                  daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or
                  without cholesterol lowering treatment), HDL cholesterol <1.0 mmol/l,
                  microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or

               -  Age 65 years or over

        Exclusion Criteria:

          1. A definite contraindication to treatment with an ACE inhibitor or a thiazide-like
             diuretic

          2. A specific indication for treatment with an ACE inhibitor other than perindopril 2-4
             mg daily (see also section 5.2.3) or a thiazide-like diuretic

          3. A definite and specific indication for treatment with gliclazide or a haemoglobin A1c
             control target of 6.5% or less

          4. A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control
             target of 6.5% or less

          5. A definite indication for long-term full-dose or bed-time insulin therapy

          6. Participation in a trial within the month prior to the Registration Visit or current
             participation in another trial

        Other potential reasons for ineligibility include:

          -  High probability of non-adherence to study treatment or follow-up

          -  Current clinical instability (e.g. a major cerebral or coronary event or
             sight-threatening retinopathy or macular oedema within the previous few weeks)

          -  Life threatening non-vascular disease other than diabetes and its complications

          -  Moderate or severe dementia

          -  Major disability that is likely to prevent regular attendance at study clinics

        Final decisions about eligibility were made at the discretion of the study investigator and
        the potential study participant, in the light of any requirements or guidance from local
        ethics committees and other regulatory bodies.