crossover randomized trial
AddHope2
Adding Liraglutide to the Backbone Therapy of Biguanide in Patients With Coronary Artery Disease and Newly Diagnosed Type-2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide plus metformin | metformin titrated to 1000 mg BID; lifestyle: not reported | 41 | ||
| A2 | Placebo Placebo plus metformin | metformin titrated to 1000 mg BID; lifestyle: not reported | 41 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 1.8 mg subcutaneous once daily A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 61.8 | ||
| age | median (years) | 64.0 | ||
| age | q1 (years) | 58.0 | ||
| age | q3 (years) | 68.0 | ||
| age | sd (years) | 7.6 | ||
| bmi | mean (kg/m2) | 31.6 | ||
| bmi | median (kg/m2) | 30.2 | ||
| bmi | q1 (kg/m2) | 27.9 | ||
| bmi | q3 (kg/m2) | 34.1 | ||
| bmi | sd (kg/m2) | 4.8 | ||
| egfr | mean (mL/min) | 80.5 | ||
| egfr | sd (mL/min) | 11 | ||
| established cvd: coronary stenosis medical therapy only | n | 2 | ||
| established cvd: coronary stenosis medical therapy only | percent | 5 | ||
| established cvd: previous cabg | n | 13 | ||
| established cvd: previous cabg | percent | 33 | ||
| established cvd: previous mi | n | 23 | ||
| established cvd: previous mi | percent | 59 | ||
| established cvd: previous pci | n | 25 | ||
| established cvd: previous pci | percent | 64 | ||
| hba1c | mean (percent) | 6.4 | ||
| hba1c | sd (percent) | 0.5 | ||
| other male | n | 31 | ||
| other male | percent | 79 | ||
| sbp | mean (mmHg) | 139.3 | ||
| sbp | sd (mmHg) | 19.4 | ||
| waist | mean (cm) | 110.4 | ||
| waist | sd (cm) | 11.2 | ||
| weight | mean (kg) | 96.9 | ||
| weight | median (kg) | 93.0 | ||
| weight | q1 (kg) | 85.0 | ||
| weight | q3 (kg) | 108.0 | ||
| weight | sd (kg) | 17.1 |
Results
10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (3 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | -0.42 percent | 0.34 | not stated; other; R0013754:Table 3 | ||
| 12 | A1 vs A2 | md | -0.37 percent | -0.57 to -0.17 | not stated; other; R0013754:Table 3 | ||
| 12 | A2 | change | -0.04 percent | 0.43 | not stated; other; R0013754:Table 3 |
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | -4.17 kg | 3.49 | not stated; other; R0013754:Table 3 | ||
| 12 | A1 vs A2 | md | -3.18 kg | -4.79 to -1.57 | not stated; other; R0013754:Table 3 | ||
| 12 | A2 | change | -0.98 kg | 2.62 | not stated; other; R0013754:Table 3 |
Systolic blood pressure change (3 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | -8.10 mmHg | 17.27 | not stated; other; R0013754:Table 3 | ||
| 12 | A1 vs A2 | md | -4.93 mmHg | -13.78 to 3.91 | not stated; other; R0013754:Table 3 | ||
| 12 | A2 | change | -3.17 mmHg | 16.07 | not stated; other; R0013754:Table 3 |
Vomiting (1 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 0 / 39 | not stated; other; R0013754:Supplement Table S5 |