Study Population

Inclusion Criteria

• Type 2 diabetes mellitus (insulin and non-insulin treated, glycosylated haemoglobin [Hb_A1c] ≤ 10%)
• Hypertension (seated systolic blood pressure/diastolic blood pressure >130/>80 mmHg or treated for hypertension)
• Macroalbuminuria (≥700 mg/g creatinine)
• Serum creatinine:
  • women 97–265 µmol/L (1.1–3.0 mg/dL)
  • men 115–285 µmol/L (1.3–3.2 mg/dL)

Exclusion Criteria

• Type 1 diabetes mellitus
• An increase of serum creatinine >30% between the screening and the end of run-in visit
• Non-diabetic renal disease
• Congestive heart failure (New York Heart Association III–IV)
• Active coronary artery disease with a recent revascularization
• Unstable angina
• Hepatic impairment
• Pregnant or nursing women; fertile women not using contraception

References