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Table 2 Baseline demographics and clinical characteristics for the subset cohorts of patients participating in either placebo controlled trials or active controlled trials

From: Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme

  Active controlled trials (n = 2) Placebo controlled trials (n = 6)
  Linagliptin (n = 1097) Active comparators* ( n = 943) Linagliptin ( n = 2541) Placebo ( n = 977)
Gender, % of patients,     
   Male/female 62.4/37.6 62.8/37.2 51.9/48.1 54.7/45.3
Age, years 60 ± 10 60 ± 10 58 ± 10 57 ± 10
BMI, kg/m2 28.6 ± 5.1 29.5 ± 4.8 28.4 ± 5,0 28.7 ± 5.0
Race, % of patients     
   White 60.2 69.9 52,0 54.0
   Black 1.8 1.9 1.0 1.3
   Asian 38.0 28.2 47.0 44.6
HbA1c, mmol/mol 62 ± 9 62 ± 10 66 ± 9 66 ± 10
HbA1c, % 7.8 ± 0.8 7.8 ± 0.9 8.2 ± 0.8 8.2 ± 0.9
FPG, mmol/L 9.1 ± 2.2 9.2 ± 2.3 9.4 ± 2.3 9.5 ± 2.3
Diabetes duration (known), % of patients
   ≤ 1 years 8.1 8.4 13.8 16.0
   1-5 years 40.6 38.8 32.7 34.4
   > 5 years 51.3 52.8 53.6 49.6
Ex-/current smoker 29.6/17.6 29.5/15.7 21.1/14.7 19.1/16.1
eGFR using CG/MDRD formulae, % of patients
   Normal 76.2/59.3 78.0/52.3 73.4/57.3 76.7/58.3
   Mildly impaired 20.6/35.5 18.7/41.4 20.8/35.3 18.3/34.9
   Moderately impaired 1.6/3.7 1.1/4.1 2.6/4.3 2.7/4.5
   Severely impaired 0/0 0/0 0.1/0.1 0.2/0.1
Framingham 10-year CV risk score
   Score, % 11.5 ± 8.1 11.6 ± 8.6 9.2 ± 8.0 9.1 ± 8.1
   Score > 15%, % of patients 34.9 37.8 25.3 24.7
  1. *Glimepiride (n = 781), voglibose (n = 162), One phase 3 trial was both placebo controlled (for the first 12 weeks) and actively controlled (for the first 26 weeks) and therefore the included 319 linagliptin patients are presented in both parts of the table. Values are mean ± SD, unless otherwise stated. BMI, body mass index; CG, Cockcroft-Gault; CV, cardiovascular; eGFR, estimated glomerular filtration rate; FPG, fasting plasma glucose; MDRD, Modification of Diet in Renal Disease study.