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Table 3 Summary of secondary endpoints

From: Efficacy of dapagliflozin versus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR)

Variable

Adjusted mean (SE)

Adjusted mean difference (95% Cl)

P-value

Dapagliflozin group (n = 168)

Sitagliptin group (n = 163)

ΔBody weight (kg)

− 2.8 (0.3)

− 0.5 (0.3)

− 2.3 (− 2.9, − 1.7)

< 0.001

ΔBMI (kg/m2)

− 1.0 (0.1)

− 0.2 (0.1)

− 0.9 (− 1.1, − 0.6)

< 0.001

ΔSystolic blood pressure (mmHg)

− 3.8 (1.5)

− 1.9 (1.5)

− 1.9 (− 5.1, 1.4)

0.26

ΔDiastolic blood pressure (mmHg)

− 2.0 (1.0)

− 1.0 (1.1)

− 1.0 (− 3.3, 1.3)

0.39

ΔFasting plasma glucose (mg/dL)

− 23.0 (2.6)

− 15.1 (2.6)

− 7.9 (− 13.6, − 2.2)

0.006

ΔFasting plasma insulin (μU/mL)a

− 1.3 (0.9)

1.0 (0.9)

− 2.3 (− 4.1, − 0.5)

NA

ΔFasting plasma insulin [ln(μU/mL)]a

− 0.17 (0.06)

0.17 (0.06)

− 0.34 (− 0.46, − 0.21)

< 0.001

ΔHbA1c (NGSP%)

− 0.9 (0.1)

− 0.9 (0.1)

0.0 (− 0.1, 0.2)

0.85

ΔHbA1c (mmol/mol)

− 9.5 (0.8)

− 9.6 (0.8)

0.2 (− 1.4, 1.7)

0.85

ΔHDL cholesterol (mg/dL)a

4.5 (0.8)

0.2 (0.8)

4.3 (2.6, 6.0)

NA

ΔHDL cholesterol [ln(mg/dL)]a

0.07 (0.01)

0.00 (0.01)

0.07 (0.04, 0.10)

< 0.001

ΔLDL cholesterol (mg/dL)a

− 0.4 (3.0)

− 3.8 (2.9)

3.4 (− 3.4, 10.1)

NA

ΔLDL cholesterol [ln(mg/dL)]a

0.00 (0.02)

− 0.04 (0.02)

0.04 (− 0.01, 0.09)

0.15

ΔTriglycerides (mg/dL)a

− 17.6 (11.0)

− 12.2 (11.1)

− 5.5 (− 30.0, 19.1)

NA

ΔTriglycerides [ln(mg/dL)]a

− 0.11 (0.04)

− 0.05 (0.04)

− 0.06 (− 0.15, 0.04)

0.25

ΔAST (IU/L)a

− 3.6 (0.9)

1.4 (0.9)

− 5.0 (− 6.9, − 3.1)

NA

ΔAST [ln(IU/L)]a

− 0.12 (0.03)

0.03 (0.03)

− 0.15 (− 0.21, − 0.09)

<0.001

ΔALT (IU/L)a

− 7.4 (1.3)

0.5 (1.3)

− 7.9 (− 10.8, − 5.0)

NA

ΔALT [ln(IU/L)]a

− 0.23 (0.03)

− 0.02 (0.03)

− 0.21 (− 0.28, − 0.13)

< 0.001

ΔHematocrit (%)

2.3 (0.2)

− 0.4 (0.2)

2.7 (2.2, 3.2)

< 0.001

ΔUA (mg/dL)

− 0.5 (0.1)

0.3 (0.1)

− 0.7 (− 0.9, − 0.5)

< 0.001

ΔBUN (mg/dL)a

1.2 (0.4)

0.0 (0.4)

1.1 (0.3, 2.0)

NA

ΔBUN [ln(mg/dL)]a

0.10 (0.02)

0.02 (0.02)

0.08 (0.03, 0.13)

0.001

ΔCreatinine (mg/dL)a

0.0 (0.0)

0.0 (0.0)

0.0 (0.0, 0.0)

NA

ΔCreatinine [ln(mg/dL)]a

0.02 (0.01)

0.04 (0.01)

− 0.02 (− 0.05, 0.00)

0.025

ΔeGFR (mL/min/1.73 m2)

− 1.4 (0.8)

− 3.5 (0.8)

2.0 (0.2, 3.9)

0.032

ΔGlucose > 10.0 mmol/L (180 mg/dL) within 24 h

 Duration (h)

− 4.4 (0.4)

− 3.9 (0.4)

− 0.5 (− 1.5, 0.4)

0.29

ΔSD of glucose (mg/dL)

− 6.0 (0.9)

− 8.6 (0.9)

2.6 (0.7, 4.5)

0.006

ΔCV glucose (%)

1.0 (0.4)

− 1.4 (0.4)

2.4 (1.5, 3.2)

< 0.001

ΔMAGE (mg/dL)

− 14.9 (2.2)

− 22.9 (2.2)

7.9 (3.1, 12.8)

0.002

ΔCONGA for 2 h (mg/dL)

− 5.5 (0.9)

− 9.5 (0.9)

3.9 (1.9, 6.0)

< 0.001

ΔCONGA for 6 h (mg/dL)

− 9.0 (1.3)

− 13.2 (1.3)

4.2 (1.2, 7.1)

0.006

  1. Data are presented as adjusted mean (SE) and adjusted mean difference (95% CI). P-values for between-group comparisons were obtained using analysis of covariance
  2. SE standard error, CI confidence interval, Δ amount of change from baseline to 24 weeks, BMI body mass index, HbA1c glycated hemoglobin, NGSP National Glycohemoglobin Standardization Program, HDL high-density lipoprotein, LDL low-density lipoprotein, AST aspartate aminotransferase, ALT alanine aminotransferase, UA uric acid, BUN blood urea nitrogen, eGFR estimated glomerular filtration rate, SD standard deviation, CV coefficient of variation, MAGE mean amplitude of glycemic excursion, CONGA continuous overall net glycemic action, NA not applicable
  3. aVariables with skewed distributions were performed log-transformed and were analyzed using log-transformed data
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Cardiovascular Diabetology

ISSN: 1475-2840