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

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
HbA_1c, 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.