parallel randomized trial
S003068
Type 2 diabetes (adults)S003068
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 0.9 mg injection once daily Liraglutide plus insulin | insulin, unchanged for 12 weeks then adjusted by SMBG; lifestyle: not reported | 9 | 8 | |
| A2 | Standard care or no added treatment Insulin alone | insulin, unchanged for 12 weeks then adjusted by SMBG; lifestyle: not reported | 10 | 9 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 0.9 mg injection once daily A1 | Standard care or no added treatment A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 57 | 60 | |
| age | sd (years) | 16 | 22 | |
| bmi | mean (kg/m2) | 27.7 | 28.2 | |
| bmi | sd (kg/m2) | 2.5 | 2.5 | |
| egfr | mean (mL/min/1.73 m2) | 71.0 | 66.3 | |
| egfr | sd (mL/min/1.73 m2) | 23.4 | 25.2 | |
| female | percent | 53 | ||
| hba1c | mean (percent) | 8.2 | 7.9 | |
| hba1c | sd (percent) | 0.5 | 0.7 | |
| insulin dose | mean (U/kg/day) | 0.48 | 0.51 | |
| insulin dose | sd (U/kg/day) | 0.17 | 0.18 | |
| metformin use | percent | 75 | 56 | |
| other agi use | percent | 13 | 0 | |
| other dpp4i use | percent | 0 | 0 | |
| other glinide use | percent | 0 | 11 | |
| other insulin regimen: basal bolus | n | 7 | 8 | |
| other male | percent | 63 | 33 | |
| other sulfonylurea use | percent | 0 | 0 | |
| other tzd use | percent | 0 | 0 | |
| sbp | mean (mmHg) | 143 | 135 | |
| sbp | sd (mmHg) | 8 | 22 | |
| sglt2i use | percent | 0 | 0 | |
| uacr | median (mg/g) | 220 | 254 | |
| uacr | q1 (mg/g) | 18 | 22 | |
| uacr | q3 (mg/g) | 346 | 420 | |
| waist | mean (cm) | 103 | 99 | |
| waist | sd (cm) | 9 | 6 | |
| weight | mean (kg) | 76.3 | 71.7 | |
| weight | sd (kg) | 13.5 | 8.5 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); descriptive only
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); 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
Results
14 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (4 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | final | 7.5 percent | 1.4 | 8 | not stated; completers; R0025603:Table 3 | |
| 24 | A2 | final | 8.1 percent | 0.6 | 9 | not stated; completers; R0025603:Table 3 | |
| 36 | A1 | final | 7.5 percent | 1.6 | 8 | not stated; completers; R0025603:Table 3 | |
| 36 | A2 | final | 7.9 percent | 0.6 | 9 | not stated; completers; R0025603:Table 3 |
Body weight change in kilograms (diabetes) (4 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | final | 73.7 kg | 12.8 | 8 | not stated; completers; R0025603:Table 3 | |
| 24 | A2 | final | 72.0 kg | 8.2 | 9 | not stated; completers; R0025603:Table 3 | |
| 36 | A1 | final | 73.7 kg | 13.5 | 8 | not stated; completers; R0025603:Table 3 | |
| 36 | A2 | final | 71.7 kg | 8.2 | 9 | not stated; completers; R0025603: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 / | not stated; other; R0025603:Results | ||||
| A2 | events | 0 / | not stated; other; R0025603:Results |
Systolic blood pressure change (4 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | final | 131 mmHg | 11 | 8 | not stated; completers; R0025603:Table 3 | |
| 24 | A2 | final | 144 mmHg | 21 | 9 | not stated; completers; R0025603:Table 3 | |
| 36 | A1 | final | 126 mmHg | 14 | 8 | not stated; completers; R0025603:Table 3 | |
| 36 | A2 | final | 143 mmHg | 14 | 9 | not stated; completers; R0025603:Table 3 |