Table 1—

Baseline characteristics of the study population at screening

Normal renal functionDegree of renal impairment (creatinine clearance, ml · min−1 · 1.73 m−2)
Mild (≥60 and ≤80)Moderate (≥40 and <60)Severe (≥30 and <40)Extreme (≥20 and <30)
Demographics
 Number of patients15164441210
 Age (years)60.4 (9.2)65.8 (7.6)69.8 (8.2)67.3 (8.3)67.3 (9.2)
Sex (%)
 Male101 (66.9)28 (43.8)18 (40.9)8 (66.7)7 (70.0)
 Female50 (33.1)36 (56.3)26 (59.1)4 (33.3)3 (30.0)
 BMI (kg/m2)29.6 (3.7)28.5 (4.0)28.4 (3.7)30.5 (4.0)28.6 (4.3)
Albumin/creatinine ratio (μg/mg creatinine)*13.6 (7.6:62.7)18.0 (8.6:36.5)75.2 (20.1:523)1028 (80.4:2,285)624 (57.8:2,755)
Creatinine (mg/dl) (mean [SD])0.8 (0.2)0.9 (0.3)1.2 (0.5)1.9 (0.6)2.6 (1.3)
Diabetic history
 Known duration of diabetes (years)8.4 (6.3)10.0 (7.0)9.9 (6.9)12.8 (6.4)10.9 (6.9)
 HbA1c (%)7.8 (1.3)7.9 (1.5)7.9 (1.3)7.1 (1.1)8.0 (1.1)
 Stimulated C-peptide (nmol/l)1.8 (0.7)1.7 (0.8)2.0 (0.9)1.9 (1.1)2.7 (0.9)
Antidiabetic medication, n (%)
 Sulphonylurea (SU)66 (43.7)33 (51.6)23 (52.3)6 (50.0)8 (80.0)
 Metformin20 (13.2)6 (9.4)3 (6.8)1 (8.3)
 Acarbose/miglitol4 (2.6)3 (4.7)2 (4.5)
 Insulin4 (2.6)1 (1.6)2 (16.7)1 (10.0)
 SU + metformin35 (23.2)11 (17.5)9 (20.5)1 (8.3)
 Insulin + OHA5 (3.3)2 (3.1)
 SU + acarbose7 (4.6)6 (9.4)6 (13.6)2 (16.7)1 (10.0)
 Metformin + acarbose2 (1.3)2 (1.3)
 Other combinations7 (4.6)
Concomitant medication, n (%)
 Hypertension94 (62.3)41 (64.1)37 (84.1)12 (100)7 (70)
 Heart disease40 (26.5)19 (29.7)11 (25.0)5 (41.7)4 (40)
 Hyperlipidemia22 (14.6)12 (18.8)8 (18.2)1 (8.3)1 (10.0)
  • Data for demographics and diabetic history are means (SD); data for medication and albuminuria n (%)

  • *

    * Expressed as median (lower quartile, upper quartile).