parallel randomized trial
NCT03010683
Effects of Agonists of Glucagon Like Peptide - 1 Receptors (GLP-1R) on Arterial Stiffness, Endothelial Glycocalyx and Coronary Flow Reserve in Patients With Coronary Artery Disease and Patients With Diabetes Mellitus
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg daily | none; lifestyle: not reported | 30 | 30 | |
| A2 | Metformin Metformin 1000 mg twice daily | none; lifestyle: not reported | 30 | 30 |
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 | Metformin A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 51 | 50 | 51 |
| age | sd (years) | 10 | 12 | 12 |
| bmi | mean (kg/m2) | 32.9 | 27.7 | |
| bmi | sd (kg/m2) | 5 | 2 | |
| egfr | mean (ml/min) | 85 | 83 | 85 |
| egfr | sd (ml/min) | 8 | 11 | 9 |
| female | n | 10 | 10 | 20 |
| hba1c | mean (percent) | 8.6 | 8.4 | |
| hba1c | sd (percent) | 2 | 1.2 | |
| other male | percent | 66.7 | 66.7 | |
| sbp | mean (mmHg) | 142 | 142 | |
| sbp | sd (mmHg) | 15 | 19 | |
| waist | mean (cm) | 109 | 97 | |
| waist | sd (cm) | 15 | 12 | |
| weight | mean (kg) | 98 | 78 | |
| weight | sd (kg) | 16 | 12 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | final | 7 percent | 1.2 | 30 | not stated; randomized; R0016601:Table 2 | |
| 26.07 | A2 | final | 7.7 percent | 1 | 30 | not stated; randomized; R0016601:Table 2 |
Body weight change in kilograms (diabetes) (2 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | final | 92 kg | 16 | 30 | not stated; randomized; R0016601:Table 2 | |
| 26.07 | A2 | final | 77 kg | 14 | 30 | not stated; randomized; R0016601:Table 2 |
Systolic blood pressure change (2 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | final | 138 mmHg | 19 | 30 | not stated; randomized; R0016601:Table 2 | |
| 26.07 | A2 | final | 141 mmHg | 16 | 30 | not stated; randomized; R0016601:Table 2 |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 30 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 0 / 30 | not stated; randomized; registry:adverse_events |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 30 | not stated; randomized; registry:adverse_events | ||||
| A2 | events | 0 / 30 | not stated; randomized; registry:adverse_events |