Study Population

Inclusion Criteria

• Type 2 diabetes mellitus (insulin and non-insulin treated, glycosylated haemoglobin [HB_A1c] ≤ 10%)
• Hypertension (seated systolic blood pressure (SBP) / diastolic blood pressure (DBP) <130/<80 mmHg)
• Macroalbuminuria (≥ 900 mg/ 24 h)
• 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

• 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 class III–IV)
• Active coronary artery disease requiring recent revascularization
• Unstable angina
• Metformin therapy
• Hepatic impairment

References