parallel randomized trial
MAGNA VICTORIA
Magnetic Resonance Assessment of Victoza Efficacy in the Regression of Cardiovascular Dysfunction In Type 2 Diabetes Mellitus and South Asian Descent
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide | metformin, sulfonylurea or insulin per guidelines; lifestyle: not reported | 22 | 22 | |
| A2 | Placebo Placebo | metformin, sulfonylurea or insulin per guidelines; lifestyle: not reported | 25 | 25 |
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 |
|---|---|---|---|
| age | mean (years) | 55 | 55 |
| age | sd (years) | 11 | 9 |
| bmi | mean (kg/m2) | 30.4 | 28.6 |
| bmi | sd (kg/m2) | 3.8 | 4.0 |
| diabetes duration | mean (years) | 19 | 17 |
| diabetes duration | sd (years) | 10 | 10 |
| established cvd: coronary artery bypass grafting | n | 1 | 2 |
| established cvd: coronary artery bypass grafting | percent | 5 | 8 |
| established cvd: nonsignificant coronary artery stenosis | n | 4 | 0 |
| established cvd: nonsignificant coronary artery stenosis | percent | 18 | 0 |
| established cvd: percutaneous coronary intervention | n | 2 | 3 |
| established cvd: percutaneous coronary intervention | percent | 9 | 12 |
| female | n | 14 | 14 |
| female | percent | 64 | 56 |
| hba1c | mean (percent) | 8.1 | 8.6 |
| hba1c | sd (percent) | 0.9 | 1.1 |
| insulin dose | mean (U/day) | 77 | 67 |
| insulin dose | sd (U/day) | 34 | 30 |
| insulin use | n | 17 | 19 |
| insulin use | percent | 77 | 76 |
| metformin use | n | 22 | 23 |
| metformin use | percent | 100 | 92 |
| other sulfonylurea use | n | 3 | 5 |
| other sulfonylurea use | percent | 14 | 20 |
| sbp | mean (mmHg) | 149 | 141 |
| sbp | sd (mmHg) | 25 | 18 |
| waist | mean (cm) | 104 | 98 |
| waist | sd (cm) | 8 | 10 |
| weight | mean (kg) | 81.9 | 77.8 |
| weight | sd (kg) | 11.0 | 12.4 |
Analyses this trial contributes to
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; 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
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- Death by suicideType 2 diabetes (adults); longest follow-up; descriptive only
- Death by suicideType 2 diabetes (adults); longest follow-up; descriptive only
Results
34 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (7 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -0.8 percent | 1.0 | 22 | not stated; modified itt; R0020542:Table 2 | |
| 26 | A1 | change | -1.0 percent | 0.8 | 20 | not stated; per protocol; R0020542:Table 3 | |
| 26 | A1 vs A2 | md | -0.4 percent | -0.9 to 0.1 | not stated; modified itt; R0020542:Table 2 | ||
| 26 | A1 vs A2 | md | -0.4 percent | -0.9 to 0.2 | not stated; modified itt; R0021697:Results | ||
| 26 | A1 vs A2 | md | -0.6 percent | -1.1 to -0.1 | not stated; per protocol; R0020542:Table 3 | ||
| 26 | A2 | change | -0.6 percent | 0.8 | 25 | not stated; modified itt; R0020542:Table 2 | |
| 26 | A2 | change | -0.6 percent | 0.8 | 24 | not stated; per protocol; R0020542:Table 3 |
Body weight change in kilograms (diabetes) (6 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -3.9 kg | 3.6 | 22 | not stated; modified itt; R0020542:Table 2 | |
| 26 | A1 | change | -4.3 kg | 3.4 | 20 | not stated; per protocol; R0020542:Table 3 | |
| 26 | A1 vs A2 | md | -3.5 kg | -5.3 to -1.8 | not stated; modified itt; R0020542:Table 2 | ||
| 26 | A1 vs A2 | md | -4.0 kg | -5.8 to -2.3 | not stated; per protocol; R0020542:Table 3 | ||
| 26 | A2 | change | -0.6 kg | 2.2 | 25 | not stated; modified itt; R0020542:Table 2 | |
| 26 | A2 | change | -0.6 kg | 2.2 | 24 | not stated; per protocol; R0020542:Table 3 |
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; safety; R0021697:Results | ||||
| A2 | events | 0 / 25 | not stated; safety; R0021697:Results |
Systolic blood pressure change (3 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -14 mmHg | 18 | not stated; modified itt; R0021697:Results | ||
| 26 | A1 vs A2 | md | -3 mmHg | -9 to 3 | not stated; modified itt; R0021697:Results | ||
| 26 | A2 | change | -7 mmHg | 15 | not stated; modified itt; R0021697:Results |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; safety; R0020542:Results | ||||
| A2 | events | 0 / 25 | not stated; safety; R0020542:Results |
Hospitalization for heart failure (2 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; safety; R0020542:Results | ||||
| A2 | events | 0 / 25 | not stated; safety; R0020542:Results |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; safety; R0020542:Results | ||||
| A2 | events | 1 / 25 | not stated; safety; R0020542:Results |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; safety; R0020542:Results | ||||
| A2 | events | 0 / 25 | not stated; safety; R0020542:Results |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 73 | 22 | not stated; safety; R0020542:Results | |||
| A2 | events | 40 | 25 | not stated; safety; R0020542:Results |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 27 | 22 | not stated; safety; R0020542:Results | |||
| A2 | events | 8 | 25 | not stated; safety; R0020542:Results |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; safety; R0020542:Results | ||||
| A2 | events | 0 / 25 | not stated; safety; R0020542:Results |
Death by suicide (2 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; safety; R0020542:Results | ||||
| A2 | events | 0 / 25 | not stated; safety; R0020542:Results |