A randomized controlled trial comparing the effects of dapagliflozin and DPP-4 inhibitors on glucose variability and metabolic parameters in patients with type 2 diabetes mellitus on insulin

Table 1 Clinical characteristics of the full analysis set

Variables	Dapagliflozin (n = 14)	DPP-4 inhibitors (n = 15)	p value
Age (years)	63.0 ± 7.7	60.0 ± 9.6	0.36
Female sex (n)	2	10	0.01
Duration of disease (years)	17.1 ± 7.9	14.8 ± 10.4	0.50
Hemoglobin A1c (%)	7.1 ± 0.8	7.4 ± 0.7	0.33
Body mass index (kg m⁻²)	26.5 ± 4.6	25.7 ± 2.5	0.61
Hemoglobin (g dL⁻¹)^a	14.1 ± 1.5	13.5 ± 1.7	0.35
Hematocrit (%)^a	41.8 ± 4.5	40.7 ± 4.8	0.53
ALT (U L⁻¹)	32 (17–45)	17 (14–22)	0.07^§
Uric acid (mg dL⁻¹)	5.6 ± 1.6	5.3 ± 1.3	0.61
Estimated GFR [mL min⁻¹ (1.73 m²)⁻¹]	68.8 (63.9–76.0)	73.7 (63.2–77.0)	0.76^§
Diabetic nephropathy (%)^a	7.1	28.6	0.33
Log UACR^a	1.93 ± 0.85	1.33 ± 0.52	0.04
The total insulin dose (U)	11 (8–22)	14 (10–20)	0.54^§
Insulin regimen (n)
MDI/mix/basal	1/3/10	1/4/10	0.95
Diabetic medication (n)
DPP-4i/Met/SU/TZD/αGI	14/10/3/1/3	15/13/3/2/1	0.80

Values are presented as the mean ± SD or median (range). p value of Dapagliflozin vs. DPP-4 inhibitors groups. ^§ Mann–Whitney U test was applied to the following factors: estimated GFR, ALT, and the total insulin dose
ALT alanine-aminotransferase, LDL low-density lipoprotein, GFR glomerular filtration rate, UACR urine albumin to creatinine ratio, MDI multiple daily injection, Mix mixed insulins, Basal long-acting insulin, DPP-4 dipeptidyl peptidase-4 inhibitors, Met metformin, SU sulphonylureas/glinides, TZD thiazolidines, αGI alpha-glucosidase inhibitors
^aData from 28 patients

ISSN: 1758-5996