| |
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
|
- *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.
