parallel randomized trial
S003108
Type 2 diabetes (adults)S003108
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide flexible dose injection once daily Liraglutide monotherapy (section 1) | lifestyle: standard | 30 | 30 | |
| A2 | Metformin Metformin monotherapy (section 1) | lifestyle: standard | 30 | 30 | |
| A3 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg monotherapy (section 2) | lifestyle: standard | 30 | 30 | |
| A4 | Liraglutide and metformin 1.2 to 1500 mg injection once daily Section 2 liraglutide plus metformin dual therapy | lifestyle: standard | 30 | 30 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide flexible dose injection once daily A1 | Metformin A2 | Liraglutide 1.8 mg subcutaneous once daily A3 | Liraglutide and metformin 1.2 to 1500 mg injection once daily A4 |
|---|---|---|---|---|---|
| age | mean (years) | 58 | 59 | 58 | 57 |
| age | sd (years) | 15 | 17 | 16 | 14 |
| bmi | mean (kg/m2) | 29.56 | 29.63 | 29.78 | 29.66 |
| bmi | sd (kg/m2) | 1.68 | 1.75 | 1.85 | 1.78 |
| diabetes duration | mean (years) | 8 | 7 | 8 | 9 |
| diabetes duration | sd (years) | 5 | 4 | 5 | 6 |
| hba1c | mean (percent) | 9.0 | 9.1 | 9.3 | 9.4 |
| hba1c | sd (percent) | 1.3 | 1.1 | 1.3 | 1.2 |
| lvef | mean (percent) | 48 | 47 | 46 | 47 |
| lvef | sd (percent) | 5 | 4 | 5 | 4 |
| other male | n | 16 | 17 | 16 | 17 |
| other male | percent | 53.3 | 46.7 | 53.3 | 46.7 |
| sbp | mean (mmHg) | 145 | 144 | 146 | 144 |
| sbp | sd (mmHg) | 9 | 8 | 7 | 8 |
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
- 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
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to gastrointestinal adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to gastrointestinal adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
36 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (8 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -2.6 percent | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A1 | final | 6.8 percent | 0.8 | 30 | not stated; randomized; R0025278:Table 2 | |
| 24 | A2 | change | -2.5 percent | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A2 | final | 6.9 percent | 0.7 | 30 | not stated; randomized; R0025278:Table 2 | |
| 24 | A3 | change | -2.6 percent | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A3 | final | 6.8 percent | 0.9 | 30 | not stated; randomized; R0025278:Table 2 | |
| 24 | A4 | change | -2.8 percent | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A4 | final | 6.7 percent | 0.7 | 30 | not stated; randomized; R0025278:Table 2 |
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 30 | not stated; randomized; R0025278:Table 4 | ||||
| A2 | events | 1 / 30 | not stated; randomized; R0025278:Table 4 | ||||
| A3 | events | 4 / 30 | not stated; randomized; R0025278:Table 4 | ||||
| A4 | events | 3 / 30 | not stated; randomized; R0025278:Table 4 |
Systolic blood pressure change (8 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -11 mmHg | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A1 | final | 134 mmHg | 7 | 30 | not stated; randomized; R0025278:Table 2 | |
| 24 | A2 | change | -4 mmHg | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A2 | final | 141 mmHg | 7 | 30 | not stated; randomized; R0025278:Table 2 | |
| 24 | A3 | change | -11 mmHg | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A3 | final | 135 mmHg | 7 | 30 | not stated; randomized; R0025278:Table 2 | |
| 24 | A4 | change | -12 mmHg | 30 | not stated; randomized; R0025278:Table 3 | ||
| 24 | A4 | final | 132 mmHg | 8 | 30 | not stated; randomized; R0025278:Table 2 |
Discontinuation due to adverse events (4 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 | ||||
| A2 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 | ||||
| A3 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 | ||||
| A4 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 30 | not stated; randomized; transient anorexia, nausea or vomit; R0025278:Table 4 | ||||
| A2 | events | 7 / 30 | not stated; randomized; transient anorexia, nausea or vomit; R0025278:Table 4 | ||||
| A3 | events | 6 / 30 | not stated; randomized; transient anorexia, nausea or vomit; R0025278:Table 4 | ||||
| A4 | events | 14 / 30 | not stated; randomized; transient anorexia, nausea or vomit; R0025278:Table 4 |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 30 | not stated; randomized; R0025278:Table 4 | ||||
| A2 | events | 2 / 30 | not stated; randomized; R0025278:Table 4 | ||||
| A3 | events | 3 / 30 | not stated; randomized; R0025278:Table 4 | ||||
| A4 | events | 1 / 30 | not stated; randomized; R0025278:Table 4 |
Discontinuation due to gastrointestinal adverse events (4 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 | ||||
| A2 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 | ||||
| A3 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 | ||||
| A4 | events | 0 / 30 | not stated; randomized; R0025278:Figure 1 |