Background
Research design and methods
Study design
Study population
Endpoints
Clinical parameters
Statistics
Results
Patients
Mean ± SD or n/N (%) | |
---|---|
Age (years) | 60.3 ± 7.6 |
Female | 23/59 (39.0) |
Weight (kg) | 87.4 ± 13 |
Height (cm) | 171 ± 11 |
BMI (kg/m2) | 29.9 ± 4.3 |
Mean duration of diabetes (years) | 5.54 ± 4.9 |
HbA1c | 6.67 ± 0.7% (49 mmol/mol) |
Glucose
| |
Fasting (mg/dl) | 132 ± 28 |
Postprandiala (mg/dl) | 178 ± 66 |
Fasting Insulin (mU/l) | 12.1 ± 7.4 |
HOMA index | 4.02 ± 2.8 |
Office blood pressure (mmHg) | |
Systolic | 130 ± 14 |
Diastolic | 79 ± 9 |
Lipids (mg/dl) | |
LDL-C | 143 ± 32 |
HDL-C | 48.2 ± 11 |
Total cholesterol | 207 ± 39 |
Triglycerides | 149 ± 66 |
Clinical characteristics after 6 weeks
Placebo | Dapagliflozin | p value placebo vs. dapagliflozin | |||
---|---|---|---|---|---|
Absolute value (change from baseline) | p value vs. baseline | Absolute value (change from baseline) | p value vs. baseline | ||
HbA1c (%)a
| 6.79 ± 0.8 (0.12 ± 0.5) | 0.064 | 6.62 ± 0.7 (−0.05 ± 0.3) | 0.224 | <0.001 |
Glucose
| |||||
Fasting (mg/dl) | 135 ± 32 (+2.3 ± 18) | 0.325 | 114 ± 19 (−18.3 ± 16) | <0.001 | <0.001 |
Postprandial (mg/dl)b
| 180 ± 67 (+1.2 ± 31) | 0.766 | 154 ± 46 (−24.8 ± 40) | <0.001 | <0.001 |
Insulin (mU/l) | 12.9 ± 10.6 (+0.8 ± 5.5) | 0.276 | 9.7 ± 5.4 (−2.4 ± 4.1) | <0.001 | 0.002 |
HOMA index | 4.48 ± 4.7 (+0.46 ± 2.5) | 0.157 | 2.77 ± 1.7 (−1.25 ± 1.8) | <0.001 | 0.001 |
BMI (kg/m2) | 29.9 ± 4.2 (+0.0 ± 0.7) | 0.846 | 29.5 ± 4.1 (−0.30 ± 0.7) | <0.001 | <0.001 |
Office blood pressure
| |||||
Systolic (mmHg) | 129 ± 13 (−1 ± 10) | 0.340 | 126 ± 12 (−4 ± 12) | 0.015 | 0.102 |
Diastolic (mmHg) | 79 ± 9 (0 ± 6) | 0.984 | 78 ± 9 (−1 ± 6) | 0.058 | 0.113 |
Heart rate (bpm) | 67.8 ± 9.6 (−1.3 ± 6.2) | 0.123 | 68.2 ± 10.6 (−0.8 ± 6.5) | 0.332 | 0.659 |
24-h ambulatory blood pressure
| |||||
Systolic (mmHg) | 129 ± 11 (−1 ± 10) | 0.682 | 126 ± 11 (−3 ± 10) | 0.010 | 0.021 |
Diastolic (mmHg) | 77 ± 7 (0 ± 6) | 0.765 | 75 ± 8 (−2 ± 6) | 0.024 | 0.027 |
Heart rate (bpm) | 75.7 ± 9.5 (+1.4 ± 6.8) | 0.172 | 74.1 ± 7.6 (−0.8 ± 6.0) | 0.351 | 0.132 |
Lipids (mg/dl) | |||||
LDL-C | 142 ± 31 (−1 ± 23) | 0.688 | 144 ± 31 (+1 ± 21) | 0.808 | 0.478 |
HDL-C | 48.5 ± 11 (+0.3 ± 4.8) | 0.607 | 48.5 ± 12 (+0.4 ± 4.4) | 0.541 | 0.954 |
Total cholesterol | 207 ± 37 (0 ± 30) | 0.937 | 209 ± 38 (+2 ± 26) | 0.584 | 0.657 |
Triglycerides | 159 ± 100 (+10 ± 91) | 0.394 | 146 ± 74 (−3 ± 63) | 0.684 | 0.043 |
Microvascular and macrovascular parameters after 6 weeks of treatment
Baseline | Placebo | Dapagliflozin | p value placebo vs. dapagliflozin | |||
---|---|---|---|---|---|---|
Mean ± SD (change from baseline) | p value vs. baseline | Mean ± SD (change from baseline) | p value vs. baseline | |||
Microvascular
| ||||||
Retinal capillary flow (AU) | 324 ± 84 | 318 ± 87 (−6 ± 45) | 0.334 | 308 ± 78 (−16 ± 53) | 0.028 | 0.157 |
Retinal capillary flow after flicker, (AU) | 351 ± 96 | 352 ± 101 (+2 ± 65) | 0.838 | 344 ± 115 (−7 ± 84) | 0.525 | 0.477 |
Outer arteriole diameter (µm) | 109 ± 11 | 109 ± 12 (+1 ± 8) | 0.599 | 109 ± 12 (+1 ± .9) | 0.572 | 0.893 |
Arteriole lumen diameter (µm) | 79.6 ± 7.6 | 79.0 ± 7.8 (-0.7 ± 6.1) | 0.435 | 80.4 ± 7.8 (+0.7 ± 6.5) | 0.410 | 0.074 |
Wall/lumen ratio | 0.36 ± 0.1 | 0.39 ± 0.1 (+0.03 ± 0.1) | 0.034 | 0.36 ± 0.1 (+0.01 ± 0.1) | 0.524 | 0.086 |
Wall thickness (µm) | 14.5 ± 3.4 | 15.1 ± 3.6 (+0.6 ± 3.1) | 0.149 | 14.5 ± 3.3 (0.0 ± 3.1) | 0.981 | 0.096 |
Wall cross section area (µm2) | 4338 ± 1291 | 4531 ± 1373 (+194 ± 1121) | 0.210 | 4378 ± 1331 (+41 ± 1176) | 0.800 | 0.231 |
Macrovascular
| ||||||
Central systolic BP (mmHg) | 121 ± 13 | 121 ± 13 (0 ± 11) | 0.756 | 118 ± 11 (−3 ± 11) | 0.035 | 0.084 |
Central diastolic BP (mmHg) | 79 ± 8 | 77 ± 8 (−2 ± 7) | 0.050 | 77 ± 7 (−2 ± 7) | 0.020 | 0.951 |
Central pulse pressure (mmHg) | 42.1 ± 11 | 43.6 ± 11 (+1.5 ± 8) | 0.185 | 40.9 ± 11 (−1.1± 10) | 0.405 | 0.050 |
Central heart rate (bpm) | 63.9 ± 8.8 | 63.2 ± 7.5 (−0.7 ± 5.8) | 0.398 | 62.3 ± 7.9 (−1.6 ± 4.5) | 0.011 | 0.359 |
Augmentation pressure (mmHg) | 12.8 ± 5.8 | 13.3 ± 6.4 (+0.4 ± 3.6) | 0.392 | 12.9 ± 6.0 (+0.1 ± 4.0) | 0.918 | 0.536 |
Augmentation index | 29.3 ± 7.9 | 29.3 ± 8.3 (0.0 ± 5.1) | 1.0 | 30.1 ± 8.4 (+0.9 ± 5.0) | 0.213 | 0.372 |
Augmentation index @75a
| 24.0 ± 7.3 | 23.6 ± 8.1 (−0.4 ± 4.6) | 0.556 | 24.1 ± 8.7 (+0.1 ± 4.6) | 0.929 | 0.603 |