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Table 1 Baseline characteristics of participants recruited in the trial (n = 244)

From: Safety and efficacy of Empagliflozin in Pakistani Muslim patients with type 2 diabetes (SAFE-PAK); a randomized clinical trial

Variables

Group A

(n = 129)

Group B

(n = 115)

p-value

Gender

 Male

60 (46.5%)

65 (56.5%)

0.118

 Female

69 (53.5%)

50 (43.5%)

Age –years

50.1 ± 10.2

50 ± 10.6

0.971

BMI

 BMI –kg/m2

29.6 ± 4.9

28.9 ± 4.9

0.331

 Normal (18.5 to < 25.0)

5 (3.9%)

11 (9.6%)

0.198

 Overweight (25.0 to < 30.0)

10 (7.8%)

9 (7.8%)

 Obese (≥ 30.0)

114 (88.4%)

95 (82.6%)

Duration of Type 2 DM-years

4.1 ± 4.3 (2; 1–22)

3.7 ± 4.7 (1; 0.3–33)

0.572

Smoking Status

 Never

112 (86.8%)

98(85.2%)

0.937

 Ex-Smoker

10 (7.8%)

10(8.7%)

 Smoker

7 (5.4%)

7(6.1%)

Comorbid Conditions

 Hypertension

38 (29.5%)

29 (25.2%)

0.459

 Dyslipidemia

25 (19.4%)

17 (14.8%)

0.342

 Obesity

23 (17.8%)

16 (13.9%)

0.405

 Non-alcoholic fatty liver disease

4 (3.1%)

8 (7%)

0.164

 Cardiovascular Disease

3 (2.3%)

1 (0.9%)

0.371

 Retinopathy

2 (1.6%)

2 (1.7%)

0.908

 Neuropathy

12 (9.3%)

12 (10.4%)

0.767

 Nephropathy

1 (0.8%)

0.344

Concomitant Medication History of Study Participants

Glucose Lowering Agents

 Biguanides

111 (86%)

85 (73.9%)

0.027

 Sulphonyl urea

32 (24.8%)

37 (32.2%)

0.202

 Dipeptidyl-peptidase 4 (DPP4) inhibitor

59 (45.7%)

59 (51.3)

0.385

 Insulin

12 (9.3%)

12 (10.4%)

0.767

Vitals of Study Participants

 Heart Rate-bpm

82.5 ± 9.3

83.2 ± 10.2

0.528

 Systolic Blood Pressure-mmHg

128.2 ± 16.2

128.3 ± 15.2

0.955

 Diastolic Blood Pressure-mmHg

81.4 ± 9.7

81.4 ± 8.7

0.947

Baseline Biochemical Profile of Study Participants

 Alanine Aminotransferase -IU/L

41.9 ± 27.0 (34; 11–154)

43.4 ± 29.6 (32; 7–161)

0.404

 Aspartate Aminotransferase -IU/L

31.4 ± 14.1 (28; 12–93)

32.3 ± 15.8 (27; 13–111)

0.398

 Alkaline phosphatase -IU/L

89.7 ± 25.0

88.7 ± 26.8

0.545

 eGFR (mL /min /1.73m2)

100.9 ± 26.3

101.0 ± 25.5

0.956

 Creatinine -mg/dl

0.8 ± 0.213

0.8 ± 0.2

0.929

Urea Nitrogen -mg/dl

14.3 ± 5.3 (13; 4–33)

14.2 ± 5.4 (13; 5–37)

0.809

Glycated Hemoglobin (HbA1c)

 NGSP

8.3% ± 0.9

8.3% ± 0.9

0.659

 IFCC

67 mmol/mol

67 mmol/mol

Fasting glucose (venous)-mg/dl

149.8 ± 45.3 (143; 70–355)

148.4 ± 43.0 (139; 58–344)

0.796

Total cholesterol-mg/dl

169.2 ± 40.6

174.5 ± 43

0.324

Low-density lipoprotein cholesterol-mg/dl

110.3 ± 40.8

114.9 ± 42.5

0.394

High-density lipoprotein cholesterol-mg/dl

37.7 ± 9.5 (36; 18–80)

37.1 ± 8.6(36; 18–60)

0.637

Triglycerides-mg/dl

181.0 ± 120.2

(154; 53–960)

196.2 ± 118.9

(181; 50–1058)

0.321

Hemoglobin-g/dl

13.5 ± 1.8

13.7 ± 2.3

0.323

White Blood Cells-103/μL

8.7 ± 2.2

8.1 ± 2.0

0.026

  1. Group A-Empagliflozin; Group B-Standard Care
  2. eGFR Estimated glomerular filtration rate