Efficacy of vildagliptin in combination with insulin in patients with type 2 diabetes and severe renal impairment

Figures & data

Table 1 Patient baseline demographic and background characteristics by treatment (randomized population)

Mean ± SD or n (%)	Vildagliptin 50 mg once daily (n = 100)	Placebo (n = 78)
Demographic variable or background characteristic*
Mean age (years)	64.1 ± 9.0	64.9 ± 11.3
Age group ≥ 65 years	53 (53.0)	41 (52.6)
Gender, male	51 (51.0)	41 (52.6)
Race
European	49 (49.0)	40 (51.3)
Hispanic or Latino	31 (31.0)	21 (26.9)
Asian	17 (17.0)	16 (20.5)
Other	3 (3.0)	1 (1.3)
Mean eGFR (mL/min/1.73 m^2)	21.7 ± 5.6	20.6 ± 6.7
Mean BMI (kg/m^2)	30.8 ± 5.8	29.6 ± 5.0
BMI ≥ 30 kg/m^2	53 (53.0)	35 (44.9)
Mean HbA1c (%)	7.7 ± 1.0	7.7 ± 1.1
HbA1c > 8.0%; n (%)	30 (30.0)	29 (37.2)
HbA1c > 9.0%; n (%)	15 (15.0)	11 (14.1)
Mean FPG (mmol/L)	8.1 ± 2.8	8.5 ± 3.5
Mean duration of T2DM (years)	18.8 ± 8.3	20.2 ± 9.5
Antidiabetic therapy at BL, n (%)
Insulin monotherapy	87 (87.0)	66 (84.6)
Insulin + OAD(s)	13 (13.0)	12 (15.4)
Insulin + SU	11 (11.0)	5 (6.4)
Mean insulin dose at baseline (U/day)	53.1 ± 35.9	49.6 ± 41.6
Mean duration of insulin use (years)	5.3 ± 5.9	5.2 ± 6.4

Note:

* There were no significant between-group differences in any baseline characteristic.

Abbreviations: BL, baseline; BMI, body mass index; GFR, glomerular filtration rate; HbA_1c, glycosylated hemoglobin; T2DM, type 2 diabetes mellitus; OAD, oral antidiabetic agent; SD, standard deviation; SU, sulfonylurea; FPG, fasting plasma glucose.

Figure 1 Time course of mean HbA_1c in patients with severe renal impairment receiving insulin therapy.

Notes: Mean ± standard error. n for vildagliptin group at baseline and week 24 = 99 and 81 patients, respectively; n for placebo group at baseline and week 24 = 77 and 59, respectively.