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