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Table 1. Characteristics of the Participants in This Cohort Study.

From: Assessing the Metabolic and Physical Effects of Combined DPP4 and SGLT2 Inhibitor Therapy in Patients with Type-2 Diabetes Mellitus: An Observational Prospective Pilot Study

Variable Overall (n = 39) DPP4i add-on group (n = 20) SGLT2i add-on group (n = 19) P
Number (male/female) 20/19 11/9 9/10 0.75†
Age (years) 64 ± 11 61 ± 12 67 ± 10 0.079‡
　≥65 years of age, n (%) 18 (46%) 7 (35%) 11 (58%) 0.20†
　<65 years of age, n (%) 21 (54%) 13 (65%) 8 (42%) 0.20†
Duration of diabetes (years) 12 ± 8 12 ± 7 12 ± 9 0.58‡
Diabetes-associated complications
　Retinopathy 4 2 2 >0.99†
　Neuropathy 8 4 4 >0.99†
　Nephropathy 11 3 8 0.082†
Medications for diabetes mellitus
　Metformin 24 15 9 0.10†
　Sulfonylurea 10 6 4 >0.99†
　Insulin 5 3 2 >0.99†
　α-Glucosidase inhibitor 1 1 0 >0.99†
Grip strength (kg) 27.5 ± 9.6 30.3 ± 10.4 24.5 ± 8.3 0.058‡
Calf circumference (cm)
　Right 36.9 ± 3.6
(n = 37)		 36.9 ± 3.7
(n = 18)		 36.9 ± 3.6
(n = 19)		 0.98‡
　Left 37.0 ± 3.1
(n = 37)		 36.8 ± 3.3
(n = 18)		 37.2 ± 3.1
(n = 19)		 0.75‡
Adherence to medication score 7 (6-7) 7 (6-7) 7 (6-7) 0.98§
GDS5 (total score) 1 (0-3) 1 (0-2) 0 (0-3) 0.25§
IPAC-SF 2 (total physical activity score) 792 (240-2,919) 1,053 (478-4,345) 438 (66-2,772) 0.050§
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Table 2. Changes in Metabolic Parameters before and after Combination Therapy of DPP4 and SGLT2 Inhibitors.

From: Assessing the Metabolic and Physical Effects of Combined DPP4 and SGLT2 Inhibitor Therapy in Patients with Type-2 Diabetes Mellitus: An Observational Prospective Pilot Study

Variable Overall
(n = 39)		 DPP4i add-on group (n = 20) SGLT2i add-on group (n = 19) P
HbA1c†, %, median (IQR)
　Baseline 7.7 (7.3-8.2) 7.7 (7.2-8.5) 7.7 (7.5-8.3) 0.92‡
　24 weeks 7.1 (6.6-7.9) 7.2 (6.6-7.9) 7.1 (6.5-7.7) 0.74‡
　Change level −0.70
(−1.2 to −0.3)		 −0.65
(−0.9 to −0.4)		 −0.70
(−1.2 to −0.3)		 0.47‡
　p‖ <0.001** <0.001** <0.001**
AST, IU/L, median (IQR)
　Baseline 20 (17-27)
(n = 38)		 20 (17-25)
(n = 19)		 19 (16-28)
(n = 19)		 0.71‡
　24 weeks 19 (17-24)
(n = 37)		 19 (15-24)
(n = 19)		 19 (17-26)
(n = 18)		 0.71‡
　Change level −2 (−4 to 1)
(n = 36)		 −1 (−5 to 1)
(n = 18)		 −2 (−4 to 0)
(n = 18)		 0.43‡
　p‖ 0.046* 0.32 0.090
ALT, IU/L, median (IQR)
　Baseline 23 (16-35) 22 (16-27) 23 (16-36) 0.75‡
　24 weeks 18 (14-28) 17 (13-28) 20 (14-26) 0.97‡
　Change level −3 (−9 to 1) −3 (−7 to 2) −6 (−9 to 0) 0.23‡
　p‖ <0.001** 0.10* 0.003**
Triglyceride, mg/dL, median (IQR)
　Baseline 148 (110-231)
(n = 39)		 184 (110-293)
(n = 20)		 142 (127-197)
(n = 19)		 0.19‡
　24 weeks 131 (97-206)
(n = 37)		 131 (97-309)
(n = 19)		 129 (91-165)
(n = 18)		 0.29‡
　Change level −19 (−76 to −18)
(n = 37)		 −19 (−94 to 5)
(n = 19)		 −11 (−63 to 26)
(n = 18)		 0.35‡
　p‖ 0.066 0.083 0.080
LDL cholesterol, mg/dL, mean ± SD
　Baseline 116 ± 28
(n = 39)		 112 ± 30
(n = 20)		 121 ± 26
(n = 19)		 0.36§
　24 weeks 114 ± 30
(n = 38)		 112 ± 26
(n = 19)		 117 ± 35
(n = 19)		 0.56§
　Change level −3 ± 20
(n = 38)		 −2 ± 17
(n = 19)		 −3 ± 23
(n = 19)		 0.89§
　p 0.38 0.53 0.54
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Table 3. Changes in Physical Parameters before and after Combination Therapy of DPP4 and SGLT2 Inhibitors.

From: Assessing the Metabolic and Physical Effects of Combined DPP4 and SGLT2 Inhibitor Therapy in Patients with Type-2 Diabetes Mellitus: An Observational Prospective Pilot Study

Variable Overall
(n = 39)		 DPP4i add-on group (n = 20) SGLT2i add-on group (n = 19) P
Body mass index, kg/m2, median (IQR)
　Baseline 25.6 (23.6-28.4) 26.1 (22.8-28.1) 25.3 (24.1-28.9) 0.84†
　24 weeks 25.3 (23.1-28.1) 25.9 (22.5-28.1) 24.1 (23.2-27.8) 0.77†
　Change level −0.49
(−1.04 to 0.17)		 0.00
(−0.60 to 0.34)		 −0.94
(−1.41 to −0.37)		 0.002†,**
　p§ 0.001** 0.78 <0.001**
Blood pressure, mmHg, median (IQR)
Systolic (n = 36) (n = 36) (n = 19)
　Baseline 127 (120-134) 127 (120-134) 130 (120-136) 0.40†
　24 weeks 128 (124-132) 130 (123-134) 128 (124-132) 0.35†
　Change level 0 (−6 to 5.75) −4 (−8 to 6) 0 (−3 to 3.5) 0.18†
　p§ 0.78 0.28 0.25
Diastolic (n = 36) (n = 17) (n = 19)
　Baseline 68 (60-76) 66 (60-76) 70 (62-78) 0.34†
　24 weeks 70 (60-74) 70 (61-74) 66 (60-74) 0.69†
　Change level 0 (−6 to 4) 0 (−3 to 8) −2 (−8 to 4) 0.21†
　p§ 0.57 0.59 0.25
Grip strength, kg, mean ± SD
　Baseline 27.5 ± 9.6 30.3 ± 10.4 24.5 ± 8.3 0.058‡
　24 weeks 29.3 ± 9.8 31.7 ± 10.5 26.7 ± 8.6 0.11‡
　Change level 1.7 ± 2.7 1.3 ± 2.2 2.1 ± 3.0 0.36‡
　p‖ <0.001** 0.014* <0.001**
Calf circumference, cm, mean ± SD
Right (n = 37) (n = 18) (n = 19)
　Baseline 36.9 ± 3.6 36.9 ± 3.7 36.9 ± 3.6 0.98‡
　24 weeks 36.4 ± 2.8 36.7 ± 2.9 36.1 ± 2.8 0.34‡
　Change level −0.66 ± 1.85 −0.22 ± 2.16 −1.05 ± 1.47 0.19‡
　p‖ 0.12 0.67 0.080
Left (n = 37) (n = 18) (n = 19)
　Baseline 37.0 ± 3.1 36.8 ± 3.3 37.2 ± 3.1 0.75‡
　24 weeks 36.3 ± 2.9 36.7 ± 2.9 36.0 ± 3.0 0.65‡
　Change level −0.55 ± 1.42 −0.06 ± 1.36 −0.94 ± 1.38 0.070‡
　p‖ 0.013* 0.67 0.006**
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Table 4. Changes in Health-Related QOL Evaluation Parameters before and after Empagliflozin and Linagliptin Combination Therapy.

From: Assessing the Metabolic and Physical Effects of Combined DPP4 and SGLT2 Inhibitor Therapy in Patients with Type-2 Diabetes Mellitus: An Observational Prospective Pilot Study

Variable Overall
(n = 39)		 DPP4i add-on group (n = 20) SGLT2i add-on group (n = 19) P
Adherence to medication score†
　Baseline 7 (6-7) 7 (6-7) 7 (6-7) 0.98‡
　24 weeks 7 (6-7) 7 (6-7) 7 (6-7) 0.93‡
　Change level 0 (0-0) 0 (0-0) 0 (0-0) 0.64‡
　p§ 0.72 >0.99 >0.99
Geriatric Depression Scale 5, total score
　Baseline 1 (0-3) 1 (0-2) 0 (0-3) 0.25‡
　24 weeks 1 (0-2) 1 (0-2) 2 (1-3) 0.12‡
　Change level 0 (−0.75 to 0) 0 (−0.5 to 0) 0 (−1 to 0) 0.91‡
　p§ 0.32 0.35 0.50
International Physical Activity Questionnaire Short Form 2, total physical activity score
　Baseline 792 (240-2,919) 1,053 (478-4,345) 438 (66-2,772) 0.050‡
　24 weeks 720 (240-2,200) 1,369 (320-3,308) 540 (135-1,260) 0.16‡
　Change level 0 (−300-342) 21 (−573-722.5) 0 (−172-310) >0.99‡
　p§ 0.59 0.76 0.57
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