Introduction
Methods
Study Design
Study Population
Randomization and Study Intervention
Study Variables and Study Schedule
Parameters | Linagliptin group (n = 21) | Metformin group (n = 22) | P value |
---|---|---|---|
Age (years) | 61.3 ± 8.7 | 58.1 ± 13.8 | 0.37 |
Gender (male) (%) | 13 (62) | 13 (59) | 1.00 |
Estimated duration of diabetes (years)a | 3.4 ± 5.9 | 3.3 ± 4.1 | 0.95 |
Current smoker (yes) | 4 (20) | 5 (23) | 1.00 |
Anti-hypertensive drugs | |||
Angiotensin-converting enzyme inhibitors | 0 (0) | 1 (4.5) | 1.00 |
Angiotensin II receptor blockers | 5 (24) | 7 (32) | 0.74 |
Direct renin inhibitors | 0 (0) | 0 (0) | – |
Calcium channel blockers | 4 (19) | 6 (27) | 0.72 |
Diuretics | 0 (0) | 0 (0) | – |
α-Adrenergic receptor antagonists | 0 (0) | 0 (0) | – |
β-Adrenergic receptor antagonists | 4 (19) | 2 (9) | 0.41 |
Lipid-lowering agents | |||
Statins | 4 (19) | 7 (32) | 0.49 |
Ezetimibe | 0 (0) | 0 (0) | – |
Fibrates | 0 (0) | 1 (4.5) | 1.00 |
Study Outcomes
OHA-Q Version 2
DTR-QOL Questionnaire
Sample Size
Statistical Analysis
Results
Participants
Parameters | Linagliptin group | Metformin group | P value (between groups) |
---|---|---|---|
BMI at baseline | 25.7 ± 4.5 (n = 21) | 26.3 ± 4.9 (n = 22) | 0.72 |
BMI at 24 weeks | 25.7 ± 4.3 (n = 20) | 26.5 ± 4.3 (n = 18) | 0.56 |
Change in BMI from baseline to week 24 | − 0.3 ± 1.4 (n = 20) | − 0.3 ± 1.2 (n = 18) | 0.90 |
HbA1c at baseline (%) | 7.1 ± 0.7 (n = 21) | 7.5 ± 1.5 (n = 21) | 0.28 |
HbA1c at 24 weeks (%) | 6.6 ± 0.5 (n = 21) | 7.1 ± 1.1 (n = 20) | 0.06 |
Change in HbA1c from baseline to week 24 | − 0.5 ± 0.4a (n = 21) | − 0.5 ± 0.9a (n = 19) | 0.78 |
Fasting blood glucose at baseline (mmol/L) | 8.1 ± 2.6 (n = 18) | 9.0 ± 3.8 (n = 19) | 0.41 |
Fasting blood glucose at 24 weeks (mmol/L) | 7.2 ± 1.3 (n = 19) | 7.6 ± 1.2 (n = 20) | 0.34 |
Change in fasting blood glucose from baseline to week 24 | − 1.0 ± 1.6a (n = 18) | − 1.8 ± 3.9 (n = 19) | 0.42 |
Total cholesterol at baseline (mmol/L) | 5.3 ± 1.0 (n = 20) | 5.3 ± 0.9 (n = 19) | 0.91 |
Total cholesterol at baseline (mmol/L) | 4.8 ± 1.0 (n = 20) | 5.2 ± 0.8 (n = 19) | 0.26 |
Change in total cholesterol from baseline to week 24 | − 0.5 ± 1.1 (n = 19) | − 0.2 ± 0.7 (n = 19) | 0.35 |
LDL cholesterol at baseline (mmol/L) | 3.2 ± 1.0 (n = 16) | 3.1 ± 0.7 (n = 16) | 0.70 |
LDL cholesterol at 24 weeks (mmol/L) | 2.8 ± 0.8 (n = 19) | 3.0 ± 0.8 (n = 18) | 0.50 |
Change in LDL cholesterol from baseline to week 24 | − 0.1 ± 1.0 (n = 15) | − 0.2 ± 0.7 (n = 14) | 0.77 |
HDL cholesterol at baseline (mmol/L) | 1.4 ± 0.4 (n = 20) | 1.4 ± 0.3 (n = 22) | 0.61 |
HDL cholesterol at 24 weeks (mmol/L) | 1.3 ± 0.4 (n = 21) | 1.4 ± 0.2 (n = 20) | 0.48 |
Change in HDL cholesterol from baseline to week 24 | 0.0 ± 0.2 (n = 20) | 0.0 ± 0.3 (n = 20) | 0.76 |
Triglycerides at baseline (mmol/L) | 1.7 ± 0.9 (n = 18) | 2.0 ± 1.3 (n = 19) | 0.33 |
Triglycerides at 24 weeks (mmol/L) | 1.4 ± 0.5 (n = 19) | 1.8 ± 1.1 (n = 20) | 0.11 |
Change in triglycerides from baseline to week 24 | − 0.3 ± 0.6 (n = 17) | − 0.3 ± 1.2 (n = 17) | 0.99 |
AST at baseline (IU/L) | 26.6 ± 10.8 (n = 21) | 30.5 ± 22.1 (n = 22) | 0.47 |
AST at 24 weeks (IU/L) | 25.0 ± 10.6 (n = 21) | 28.1 ± 16.5 (n = 20) | 0.49 |
Change in AST from baseline to week 24 | − 1.5 ± 6.3 (n = 21) | − 4.1 ± 10.6 (n = 20) | 0.35 |
ALT at baseline (IU/L) | 26.9 ± 16.7 (n = 21) | 37.1 ± 32.1 (n = 22) | 0.20 |
ALT at 24 weeks (IU/L) | 21.3 ± 10.4 (n = 21) | 33.3 ± 24.0 (n = 20) | 0.06 |
Change in ALT from baseline to week 24 | − 4.5 ± 8.9a (n = 21) | − 6.5 ± 19.4 (n = 20) | 0.67 |
eGFR at baseline (mL/min/1.73 m2) | 76.7 ± 17.2 (n = 21) | 92.0 ± 21.4 (n = 22) | 0.014 |
eGFR at baseline at 24 weeks (mL/min/1.73 m2) | 76.5 ± 11.9(n = 21) | 90.7 ± 19.8 (n = 20) | 0.008 |
Change in eGFR from baseline to week 24 | − 0.2 ± 14.1a (n = 21) | − 3.7 ± 12.0 (n = 20) | 0.41 |
Urinary albumin excretion at baseline (mg/g creatinine) | 15.7 (5.0, 43.2) (n = 10) | 20.0 (5.0, 33.4) (n = 15) | 0.91 |
Urinary albumin excretion at 24 weeks (mg/g creatinine) | 7.0 (3.3, 10.0) (n = 13) | 22.5 (5.0, 39.8) (n = 14) | 0.049 |
Change in urinary albumin excretion from baseline to week 24 | − 8.0 (− 15.6, 0.3) (n = 9) | − 0.7 (− 6.7, 8.0) (n = 12) | 0.20 |
Systolic BP at baseline (mmHg) | 136 ± 16 (n = 21) | 138 ± 14 (n = 22) | 0.69 |
Systolic BP at 24 weeks (mmHg) | 131 ± 16 (n = 21) | 129 ± 7 (n = 20) | 0.69 |
Change in systolic BP from baseline to week 24 | − 4.8 ± 14.4 (n = 21) | − 8.9 ± 15.4a (n = 20) | 0.38 |
Diastolic BP at baseline (mmHg) | 80 ± 14 (n = 21) | 79 ± 13 (n = 22) | 0.83 |
Diastolic BP at 24 weeks (mmHg) | 79 ± 13 (n = 21) | 78 ± 7 (n = 19) | 0.72 |
Change in diastolic from baseline to week 24 | − 1.1 ± 7.9 (n = 21) | − 3.2 ± 12.5a (n = 19) | 0.53 |
OHA-Q Score and Change in DTR-QOL Scores
Parameter | Linagliptin group (n = 21) | Metformin group (n = 20) | P value (between groups) |
---|---|---|---|
Total score | 55.0 (48.0, 58.0) | 46.0 (39.5, 56.5) | 0.09 |
Subscale 1 score | 26.0 (22.0, 27.0) | 18.5 (15.5, 24.5) | 0.003 |
Subscale 2 score | 23.0 (20.0, 27.0) | 22.5 (19.0, 27.0) | 0.70 |
Subscale 3 score | 6.0 (5.0, 7.0) | 6.0 (5.0, 6.5) | 0.83 |
Question 1 | 2.0 (2.0, 3.0) | 2.0 (1.0, 2.5) | 0.022 |
Question 2 | 3.0 (3.0, 3.0) | 2.5 (2.0, 3.0) | 0.024 |
Question 3 | 3.0 (2.0, 3.0) | 2.0 (1.5, 3.0) | 0.05 |
Question 4 | 3.0 (3.0, 3.0) | 3.0 (2.0, 3.0) | 0.08 |
Question 5 | 2.0 (2.0, 3.0) | 2.0 (2.0, 3.0) | 0.51 |
Question 6 | 3.0 (2.0, 3.0) | 2.0 (1.0, 2.0) | <0.001 |
Question 7 | 3.0 (2.0, 3.0) | 2.0 (1.0, 2.5) | 0.008 |
Question 8 | 3.0 (3.0, 3.0) | 2.0 (1.0, 3.0) | 0.001 |
Question 9 | 3.0 (3.0, 3.0) | 2.0 (2.0, 3.0) | 0.002 |
Question 10 | 2.0 (1.0, 3.0) | 2.0 (1.0, 2.0) | 0.97 |
Question 11 | 2.0 (2.0, 3.0) | 2.0 (1.0, 2.0) | 0.11 |
Question 12 | 2.0 (2.0, 3.0) | 2.0 (1.5, 2.0) | 0.09 |
Question 13 | 2.0 (2.0, 3.0) | 2.0 (2.0, 3.0) | 0.87 |
Question 14 | 2.0 (1.0, 2.0) | 2.0 (1.0, 3.0) | 0.50 |
Question 15 | 2.0 (1.0, 2.0) | 2.0 (2.0, 2.0) | 0.83 |
Question 16 | 2.0 (2.0, 3.0) | 2.0 (1.5, 3.0) | 0.86 |
Question 17 | 2.0 (2.0, 3.0) | 2.0 (2.0, 3.0) | 0.92 |
Question 18 | 2.0 (2.0, 3.0) | 2.0 (1.5, 2.0) | 0.13 |
Question 19 | 2.0 (1.0, 2.0) | 2.0 (1.0, 2.5) | 0.50 |
Question 20 | 2.0 (1.0, 3.0) | 2.0 (1.5, 2.0) | 0.99 |
Question 21 | 3.0 (2.0, 3.0) | 2.0 (2.0, 3.0) | 0.45 |
Question 22 | 2.0 (2.0, 2.0) | 2.0 (2.0, 2.0) | 0.78 |
Question 23 | 2.0 (2.0, 2.0) | 2.0 (2.0, 2.0) | 0.99 |
Parameters | Linagliptin group | Metformin group | P value (between groups) |
---|---|---|---|
Total score at baseline | 65.5 (43.7, 76.4) (n = 21) | 64.9 (52.9, 82.5) (n = 20) | 0.62 |
Total score at 24 weeks | 80.5 (67.8, 92.0) (n = 21) | 77.9 (53.7, 89.9) (n = 20) | 0.45 |
Change in total score from baseline to week 24 | 9.8 (2.3, 21.8)a (n = 21) | 10.9 (1.1, 21.3) (n = 18) | 0.75 |
Domain 1 score at baseline | 73.1 (46.2, 84.6) (n = 21) | 68.6 (46.2, 91.0) (n = 22) | 0.72 |
Domain 1 score at 24 weeks | 87.2 (64.1, 96.2) (n = 21) | 85.3 (55.8, 93.6) (n = 20) | 0.49 |
Change in domain 1 score from baseline to week 24 | 7.7 (0.0, 16.7)a (n = 21) | 3.2 (− 2.6, 26.3) (n = 20) | 0.75 |
Domain 2 score at baseline | 56.3 (43.8, 75.0) (n = 21) | 66.7 (50.0, 79.2) (n = 22) | 0.47 |
Domain 2 score at 24 weeks | 79.2 (58.3, 91.7) (n = 21) | 64.6 (43.8, 93.8) (n = 20) | 0.47 |
Change in domain 2 score from baseline to week 24 | 16.7 (0.0, 33.3)a (n = 21) | 8.3 (− 1.0, 20.8) (n = 20) | 0.19 |
Domain 3 score at baseline | 95.8 (50.0, 100.0) (n = 21) | 75.8 (50.0, 100.0) (n = 22) | 0.70 |
Domain 3 score at 24 weeks | 100.0 (83.3, 100.0) (n = 21) | 91.7 (50.0, 100.0) (n = 20) | 0.23 |
Change in domain 3 score from baseline to week 24 | 0.0 (0.0, 33.3) (n = 21) | 4.2 (0.0, 37.5) (n = 20) | 0.85 |
Domain 4 score at baseline | 50.0 (45.8, 58.3) (n = 21) | 54.2 (50.0, 66.7) (n = 20) | 0.24 |
Domain 4 score at 24 weeks | 62.5 (54.2, 79.2) (n = 21) | 62.5 (50.0, 68.8) (n = 20) | 0.56 |
Change in domain 4 score from baseline to week 24 | 16.7 (8.3, 25.0)a (n = 21) | 6.3 (− 4.2, 16.7) (n = 18) | 0.15 |
Each item at 24 weeks (change from baseline) | |||
Question 1 | 0.0 (0.0, 2.0) (n = 21) | 0.5 (0.0, 2.0) (n = 20) | 0.75 |
Question 2 | 0.0 (0.0, 1.0) (n = 21) | 1.5 (0.0, 3.5) (n = 20) | 0.39 |
Question 3 | 1.0 (0.0, 3.0) (n = 21) | 0.0 (− 1.0, 2.0) (n = 20) | 0.43 |
Question 4 | 0.0 (0.0, 1.0) (n = 21) | 0.0 (0.0, 1.0) (n = 20) | 0.88 |
Question 5 | 0.0 (0.0, 2.0) (n = 21) | 0.0 (0.0, 1.0) (n = 20) | 0.29 |
Question 6 | 0.0 (0.0, 3.0) (n = 21) | 0.0 (0.0, 1.0) (n = 20) | 0.27 |
Question 7 | 0.0 (0.0, 2.0) (n = 21) | 0.5 (− 1.0, 3.0) (n = 20) | 0.99 |
Question 8 | 0.0 (0.0, 2.0) (n = 21) | 0.5 (− 0.5, 3.0) (n = 20) | 0.61 |
Question 9 | 0.0 (− 1.0, 1.0) (n = 21) | 0.0 (− 1.0, 2.0) (n = 20) | 0.72 |
Question 10 | 1.0 (0.0., 3.0) (n = 21) | 0.0 (− 0.5, 1.5) (n = 20) | 0.15 |
Question 11 | 1.0 (0.0, 2.0) (n = 21) | 1.0 (− 0.5, 2.0) (n = 20) | 0.33 |
Question 12 | 0.0 (0.0, 3.0) (n = 21) | 0.0 (0.0, 1.0) (n = 20) | 0.17 |
Question 13 | 0.0 (0.0, 3.0) (n = 21) | 0.0 (− 1.0, 2.0) (n = 20) | 0.21 |
Question 14 | 1.0 (0.0, 2.0) (n = 21) | 0.0 (0.0, 2.5) (n = 20) | 0.27 |
Question 15 | 0.0 (− 1.0, 3.0) (n = 21) | 0.5 (0.0, 2.0) (n = 20) | 0.67 |
Question 16 | 0.0 (0.0, 1.0) (n = 21) | 0.0 (− 0.5, 2.5) (n = 20) | 0.80 |
Question 17 | 0.0 (0.0, 3.0) (n = 21) | 0.0 (0.0, 2.5) (n = 20) | 0.73 |
Question 18 | 0.0 (0.0, 3.0) (n = 21) | 0.0 (− 0.5, 2.5) (n = 20) | 0.62 |
Question 19 | 0.0 (0.0, 2.0) (n = 21) | 0.0 (0.0, 1.0) (n = 20) | 0.52 |
Question 20 | 1.0 (0.0, 2.0) (n = 21) | 0.5 (− 0.5, 3.0) (n = 20) | 0.73 |
Question 21 | 2.0 (0.0, 2.0) (n = 21) | 0.0 (− 1.0, 2.0) (n = 20) | 0.40 |
Question 22 | 1.0 (0.0, 3.0) (n = 21) | 0.0 (− 2.0, 1.0) (n = 20) | 0.03 |
Question 23 | 1.0 (0.0, 2.0) (n = 21) | 1.0 (− 1.5, 2.0) (n = 20) | 0.29 |
Question 24 | 0.0 (0.0, 2.0) (n = 21) | 0.0 (− 0.5, 1.0) (n = 20) | 0.51 |
Question 25 | 1.0 (0.0, 2.0) (n = 21) | 0.0 (0.0, 1.0) (n = 20) | 0.17 |
Question 26 | 2.0 (0.0, 3.0) (n = 21) | 1.0 (0.0, 2.0) (n = 19) | 0.26 |
Question 27 | 1.0 (0.0, 2.0) (n = 21) | 0.0 (− 1.0, 1.0) (n = 19) | 0.21 |
Question 28 | 0.0 (0.0, 1.0) (n = 21) | 0.0 (− 1.0, 1.0) (n = 18) | 0.86 |
Question 29 | 2.0 (0.0, 3.0) (n = 21) | 1.0 (0.0, 2.0) (n = 18) | 0.42 |