J Endocrinol Metab

Journal of Endocrinology and Metabolism, ISSN 1923-2861 print, 1923-287X online, Open Access

Article copyright, the authors; Journal compilation copyright, J Endocrinol Metab and Elmer Press Inc

Journal website http://www.jofem.org

Original Article

Volume 9, Number 5, October 2019, pages 151-158

Sitagliptin Versus Ipragliflozin for Type 2 Diabetes in Clinical Practice

**Table 1.** Characteristics of the Patients Treated With Sitagliptin or Ipragliflozin
Characteristic	Sitagliptin (ASSET-K) (n = 1,313)	Ipragliflozin (ASSIGN-K) (n = 431)	P value
Data are the n (%) or mean ± standard deviation. ^aP < 0.05 Student’s t-test; ^bP < 0.05 Chi-square test. BMI: body mass index; HbA1c: hemoglobin A1c; eGFR: estimated glomerular filtration rate; DPP4: dipeptidyl peptidase-4; GLP-1: glucagon-like peptide-1; SGLT2: sodium-glucose cotransporter-2.
Age (years)	62.9 ± 11.5	55.5 ± 11.4	< 0.001^a
Male/female	740/573	219/212	0.045^b
Body weight (kg)	64.7 ± 14	99.6 ± 12.5	< 0.001^a
BMI (kg/m²)	24.7 ± 4.4	29.4 ± 5.3	< 0.001^a
Smoker	373 (28.4)	280 (65)	< 0.001^b
Drinking alcohol	445 (33.9)	155 (36)	0.432
Hemoglobin A1c (%)	8.01 ± 1.15	8.04 ± 1.42	0.710
Duration of diabetes (years)	12.1 ± 8.1	9.6 ± 7.4	< 0.001^a
Mean blood pressure (mm Hg)	93.7 ± 10.1	97.3 ± 11.6	< 0.001^a
eGFR (mL/min/1.73 m²)	82 ± 22.3	83.3 ± 21.2	0.298
Complications
Cerebrovascular disease	68 (5.2)	19 (4.4)	0.524
Myocardial infarction/angina	81 (6.2)	25 (5.8)	0.781
Arteriosclerosis obliterans	26 (2)	9 (2.1)	0.890
Hypertension	605 (46.1)	247 (57.3)	< 0.001^b
Dyslipidemia	611 (46.5)	282 (65.4)	< 0.001^b
Prescribing pattern
Initial treatment	181 (13.8)	55 (12.8)
Add-on	695 (52.9)	339 (78.7)	< 0.001^b
Switching	437 (33.3)	37 (8.6)
Medications
Sulfonylureas	833 (63.4)	133 (30.9)	< 0.001^b
Biguanides	608 (46.3)	222 (51.5)	0.061
Thiazolidinediones	293 (22.3)	58 (13.5)	< 0.001^b
Glinides	25 (1.9)	28 (6.5)	< 0.001^b
Alpha-glucosidase inhibitors	112 (8.5)	41 (9.5)	0.532
DPP4 inhibitors	1,313 (100)	258 (59.9)	< 0.001^b
GLP-1 analogues	0 (0)	6 (1.4)	< 0.001^b
SGLT2 inhibitors	0 (0)	431 (100)	< 0.001^b
Insulin	0 (0)	78 (18.1)	< 0.001^b

Table 1. Characteristics of the Patients Treated With Sitagliptin or Ipragliflozin

Characteristic

Sitagliptin (ASSET-K) (n = 1,313)

Ipragliflozin (ASSIGN-K) (n = 431)

P value

New: 876

New: 394

Switched: 437

Switched: 37

Data are the n (%) or mean ± standard deviation. ^aP < 0.05 Student’s t-test; ^bP < 0.05 Chi-square test. BMI: body mass index; HbA1c: hemoglobin A1c; eGFR: estimated glomerular filtration rate; DPP4: dipeptidyl peptidase-4; GLP-1: glucagon-like peptide-1; SGLT2: sodium-glucose cotransporter-2.

Age (years)

62.9 ± 11.5

55.5 ± 11.4

< 0.001^a

Male/female

740/573

219/212

0.045^b

Body weight (kg)

64.7 ± 14

99.6 ± 12.5

< 0.001^a

BMI (kg/m²)

24.7 ± 4.4

29.4 ± 5.3

< 0.001^a

Smoker

373 (28.4)

280 (65)

< 0.001^b

Drinking alcohol

445 (33.9)

155 (36)

0.432

Hemoglobin A1c (%)

8.01 ± 1.15

8.04 ± 1.42

0.710

Duration of diabetes (years)

12.1 ± 8.1

9.6 ± 7.4

< 0.001^a

Mean blood pressure (mm Hg)

93.7 ± 10.1

97.3 ± 11.6

< 0.001^a

eGFR (mL/min/1.73 m²)

82 ± 22.3

83.3 ± 21.2

0.298

Complications

Cerebrovascular disease

68 (5.2)

19 (4.4)

0.524

Myocardial infarction/angina

81 (6.2)

25 (5.8)

0.781

Arteriosclerosis obliterans

26 (2)

9 (2.1)

0.890

Hypertension

605 (46.1)

247 (57.3)

< 0.001^b

Dyslipidemia

611 (46.5)

282 (65.4)

< 0.001^b

Prescribing pattern

Initial treatment

181 (13.8)

55 (12.8)

Add-on

695 (52.9)

339 (78.7)

< 0.001^b

Switching

437 (33.3)

37 (8.6)

Medications

Sulfonylureas

833 (63.4)

133 (30.9)

< 0.001^b

Biguanides

608 (46.3)

222 (51.5)

0.061

Thiazolidinediones

293 (22.3)

58 (13.5)

< 0.001^b

Glinides

25 (1.9)

28 (6.5)

< 0.001^b

Alpha-glucosidase inhibitors

112 (8.5)

41 (9.5)

0.532

DPP4 inhibitors

1,313 (100)

258 (59.9)

< 0.001^b

GLP-1 analogues

0 (0)

6 (1.4)

< 0.001^b

SGLT2 inhibitors

0 (0)

431 (100)

< 0.001^b

Insulin

0 (0)

78 (18.1)

< 0.001^b

**Table 2.** Changes of HbA1c, BMI, Mean Blood Pressure, and eGFR
Item	Sitagliptin (ASSET-K)	Ipragliflozin (ASSIGN-K)	Difference	P value
P values were adjusted by analysis of covariance for age, sex, baseline duration of diabetes, baseline mean BMI, baseline mean blood pressure, baseline eGFR, and baseline HbA1c. HbA1c: hemoglobin A1c; BMI: body mass index; eGFR: estimated glomerular filtration rate; LS: least squares; SE: standard error. *P < 0.05.
eGFR (mL/min/1.73 m²)
Δ 4 weeks	364	-2.45	0.58	340	-3.57	0.60	1.12	0.89	0.209
Δ 12 weeks	364	-2.84	0.58	340	-1.97	0.61	0.87	0.90	0.333
Δ 24 weeks	364	-4.15	0.59	340	-1.88	0.61	2.28	0.91	0.012*
HbA1c (%)
Δ 4 weeks	719	-0.34	0.02	343	-0.42	0.03	0.08	0.03	0.012*
Δ 12 weeks	719	-0.68	0.03	343	-0.78	0.04	0.09	0.05	0.083
Δ 24 weeks	719	-0.72	0.03	343	-0.82	0.04	0.09	0.05	0.089
BMI (kg/m²)
Δ 4 weeks	653	0.00	0.02	344	-0.38	0.04	0.38	0.05	< 0.001*
Δ 12 weeks	653	-0.03	0.03	344	-0.65	0.05	0.62	0.06	< 0.001*
Δ 24 weeks	653	-0.10	0.04	344	-0.76	0.06	0.66	0.07	< 0.001*
Mean blood pressure (mm Hg)
Δ 4 weeks	679	-0.70	0.33	340	-3.36	0.48	2.66	0.62	< 0.001*
Δ 12 weeks	679	-1.67	0.34	340	-2.18	0.50	0.51	0.64	0.428
Δ 24 weeks	679	-0.66	0.36	340	-2.50	0.53	1.84	0.68	0.007*

Table 2. Changes of HbA1c, BMI, Mean Blood Pressure, and eGFR

Item

Sitagliptin (ASSET-K)

Ipragliflozin (ASSIGN-K)

Difference

P value

LS mean

P values were adjusted by analysis of covariance for age, sex, baseline duration of diabetes, baseline mean BMI, baseline mean blood pressure, baseline eGFR, and baseline HbA1c. HbA1c: hemoglobin A1c; BMI: body mass index; eGFR: estimated glomerular filtration rate; LS: least squares; SE: standard error. *P < 0.05.

eGFR (mL/min/1.73 m²)

Δ 4 weeks

364

-2.45

0.58

340

-3.57

0.60

1.12

0.89

0.209

Δ 12 weeks

364

-2.84

0.58

340

-1.97

0.61

0.87

0.90

0.333

Δ 24 weeks

364

-4.15

0.59

340

-1.88

0.61

2.28

0.91

0.012*

HbA1c (%)

Δ 4 weeks

719

-0.34

0.02

343

-0.42

0.03

0.08

0.03

0.012*

Δ 12 weeks

719

-0.68

0.03

343

-0.78

0.04

0.09

0.05

0.083

Δ 24 weeks

719

-0.72

0.03

343

-0.82

0.04

0.09

0.05

0.089

BMI (kg/m²)

Δ 4 weeks

653

0.00

0.02

344

-0.38

0.04

0.38

0.05

< 0.001*

Δ 12 weeks

653

-0.03

0.03

344

-0.65

0.05

0.62

0.06

< 0.001*

Δ 24 weeks

653

-0.10

0.04

344

-0.76

0.06

0.66

0.07

< 0.001*

Mean blood pressure (mm Hg)

Δ 4 weeks

679

-0.70

0.33

340

-3.36

0.48

2.66

0.62

< 0.001*

Δ 12 weeks

679

-1.67

0.34

340

-2.18

0.50

0.51

0.64

0.428

Δ 24 weeks

679

-0.66

0.36

340

-2.50

0.53

1.84

0.68

0.007*

**Table 3.** Changes of HbA1c, BMI, Mean Blood Pressure, and eGFR (Excluding Switched Patients)
Item	Sitagliptin (ASSET-K)	Ipragliflozin (ASSIGN-K)	Difference	P value
P values were adjusted by analysis of covariance for age, sex, baseline duration of diabetes, baseline mean BMI, baseline mean blood pressure, baseline eGFR, and baseline HbA1c. HbA1c: hemoglobin A1c; BMI: body mass index; eGFR: estimated glomerular filtration rate; LS: least squares; SE: standard error. *P < 0.05.
eGFR (mL/min/1.73 m²)
Δ 4 weeks	206	-2.86	0.82	309	-3.86	0.65	1.00	1.10	0.367
Δ 12 weeks	206	-4.07	0.78	309	-2.44	0.62	1.63	1.05	0.121
Δ 24 weeks	206	-4.69	0.81	309	-2.50	0.65	2.19	1.10	0.047*
HbA1c (%)
Δ 4 weeks	452	-0.38	0.02	311	-0.46	0.03	0.08	0.04	0.029*
Δ 12 weeks	452	-0.81	0.04	311	-0.89	0.04	0.08	0.06	0.190
Δ 24 weeks	452	-0.87	0.04	311	-0.93	0.05	0.06	0.06	0.327
BMI (kg/m²)
Δ 4 weeks	409	-0.02	0.03	312	-0.37	0.03	0.34	0.04	< 0.001*
Δ 12 weeks	409	-0.04	0.04	312	-0.62	0.05	0.58	0.07	< 0.001*
Δ 24 weeks	409	-0.14	0.05	312	-0.73	0.06	0.59	0.09	< 0.001*
Mean blood pressure (mm Hg)
Δ 4 weeks	426	-0.58	0.42	308	-3.27	0.50	2.69	0.69	< 0.001*
Δ 12 weeks	426	-1.81	0.45	308	-2.38	0.54	0.58	0.74	0.434
Δ 24 weeks	426	-1.06	0.47	308	-2.41	0.56	1.35	0.77	0.081

Table 3. Changes of HbA1c, BMI, Mean Blood Pressure, and eGFR (Excluding Switched Patients)

Item

Sitagliptin (ASSET-K)

Ipragliflozin (ASSIGN-K)

Difference

P value

LS mean

eGFR (mL/min/1.73 m²)

Δ 4 weeks

206

-2.86

0.82

309

-3.86

0.65

1.00

1.10

0.367

Δ 12 weeks

206

-4.07

0.78

309

-2.44

0.62

1.63

1.05

0.121

Δ 24 weeks

206

-4.69

0.81

309

-2.50

0.65

2.19

1.10

0.047*

HbA1c (%)

Δ 4 weeks

452

-0.38

0.02

311

-0.46

0.03

0.08

0.04

0.029*

Δ 12 weeks

452

-0.81

0.04

311

-0.89

0.04

0.08

0.06

0.190

Δ 24 weeks

452

-0.87

0.04

311

-0.93

0.05

0.06

0.327

BMI (kg/m²)

Δ 4 weeks

409

-0.02

0.03

312

-0.37

0.03

0.34

0.04

< 0.001*

Δ 12 weeks

409

-0.04

0.04

312

-0.62

0.05

0.58

0.07

< 0.001*

Δ 24 weeks

409

-0.14

0.05

312

-0.73

0.06

0.59

0.09

< 0.001*

Mean blood pressure (mm Hg)

Δ 4 weeks

426

-0.58

0.42

308

-3.27

0.50

2.69

0.69

< 0.001*

Δ 12 weeks

426

-1.81

0.45

308

-2.38

0.54

0.58

0.74

0.434

Δ 24 weeks

426

-1.06

0.47

308

-2.41

0.56

1.35

0.77

0.081