parallel randomized trial
S002928
Type 2 diabetes (adults)S002928
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | metformin 1500 mg/day; lifestyle: standard | 41 | 35 | |
| A2 | Polyethylene glycol loxenatide 300 µg injection once weekly PEG-Loxe 300 ug | metformin 1500 mg/day; lifestyle: standard | 41 | 35 | |
| A3 | Polyethylene glycol loxenatide 400 µg injection once weekly PEG-Loxe 400 ug | metformin 1500 mg/day; lifestyle: standard | 41 | 35 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Polyethylene glycol loxenatide 300 µg injection once weekly A2 | Polyethylene glycol loxenatide 400 µg injection once weekly A3 |
|---|---|---|---|---|
| age | mean (years) | 31.95 | 33.77 | 29.49 |
| age | sd (years) | 7.88 | 8.23 | 7.03 |
| bmi | median (kg/m2) | 53.34 | 54.01 | 54.13 |
| bmi | q1 (kg/m2) | 51.20 | 51.21 | 52.07 |
| bmi | q3 (kg/m2) | 59.56 | 56.47 | 58.82 |
| female | n | 13 | 11 | 10 |
| female | percent | 37.1 | 31.4 | 28.6 |
| hba1c | median (percent) | 7.6 | 7.2 | 7.1 |
| hba1c | q1 (percent) | 6.8 | 6.5 | 6.7 |
| hba1c | q3 (percent) | 8.5 | 9.7 | 8.1 |
| sbp | mean (mmHg) | 139.20 | 142.00 | 143.40 |
| sbp | sd (mmHg) | 15.16 | 16.71 | 18.32 |
| waist | median (cm) | 152 | 152 | 154 |
| waist | q1 (cm) | 144 | 147 | 150 |
| waist | q3 (cm) | 170 | 159 | 162 |
| weight | mean (kg) | 169.09 | 168.63 | 170.71 |
| weight | sd (kg) | 31.00 | 24.98 | 20.09 |
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
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 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
- 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
- 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
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 10 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 15 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); descriptive only
- Weight loss of 15 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); descriptive only
- 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
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 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
57 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 |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -0.50 percent | -0.64 to -0.36 | 35 | not stated; completers; R0007034:Figure 3A | |
| 24 | A2 | change | -1.02 percent | -1.16 to -0.88 | 35 | not stated; completers; R0007034:Results | |
| 24 | A3 | change | -1.34 percent | -1.48 to -1.20 | 35 | not stated; completers; R0007034:Results |
Body weight change in kilograms (diabetes) (8 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -6.75 kg | -9.51 to -3.99 | 35 | not stated; completers; R0007034:Table 2 | |
| 24 | A1 | final | 162.37 kg | 29.02 | 35 | not stated; completers; R0007034:Table 2 | |
| 24 | A1 vs A2 | md | 9.59 kg | 4.80 to 14.38 | not stated; completers; R0007034:Table 2 | ||
| 24 | A1 vs A3 | md | 14.39 kg | 9.60 to 19.18 | not stated; completers; R0007034:Table 2 | ||
| 24 | A2 | change | -16.34 kg | -19.10 to -13.58 | 35 | not stated; completers; R0007034:Table 2 | |
| 24 | A2 | final | 152.43 kg | 22.71 | 35 | not stated; completers; R0007034:Table 2 | |
| 24 | A3 | change | -21.14 kg | -23.90 to -18.37 | 35 | not stated; completers; R0007034:Table 2 | |
| 24 | A3 | final | 149.37 kg | 18.86 | 35 | not stated; completers; R0007034:Table 2 |
HbA1c below 7 percent (3 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 40.0 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A2 | responders | 62.9 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A3 | responders | 88.6 | 35 | not stated; completers; R0007034:Results |
Level 2 or 3 hypoglycemia (participants) (9 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 35 | not stated; safety; R0007034:Table 4 | ||||
| A1 | events | 0 / 35 | not stated; safety; R0007034:Table 4 | ||||
| A1 | events | 0 / 35 | not stated; safety; R0007034:Table 4 | ||||
| A2 | events | 0 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A2 | events | 0 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A2 | events | 0 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A3 | events | 0 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A3 | events | 0 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A3 | events | 0 / 36 | not stated; safety; R0007034:Table 4 |
Systolic blood pressure change (3 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -0.79 mmHg | -7.64 to 6.17 | 35 | not stated; completers; R0007034:Table 3 | |
| 24 | A2 | change | 0.48 mmHg | -6.32 to 7.29 | 35 | not stated; completers; R0007034:Table 3 | |
| 24 | A3 | change | -0.74 mmHg | -7.58 to 6.10 | 35 | not stated; completers; R0007034:Table 3 |
Percent body weight change (3 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | percent change | -3.80 percent | 35 | not stated; completers; R0007034:Figure 2C | ||
| 24 | A2 | percent change | -9.48 percent | 35 | not stated; completers; R0007034:Figure 2C | ||
| 24 | A3 | percent change | -12.49 percent | 35 | not stated; completers; R0007034:Figure 2C |
Weight loss of 5 percent or more (4 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 54.1 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A1 | responders | 51.4 | 35 | not stated; completers; R0007034:Figure 2E | ||
| 24 | A2 | responders | 91.4 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A3 | responders | 97.1 | 35 | not stated; completers; R0007034:Results |
Weight loss of 10 percent or more (3 lines; O11B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 17.1 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A2 | responders | 74.3 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A3 | responders | 82.9 | 35 | not stated; completers; R0007034:Results |
Weight loss of 15 percent or more (3 lines; O11C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 11.45 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A2 | responders | 57.1 | 35 | not stated; completers; R0007034:Results | ||
| 24 | A3 | responders | 71.4 | 35 | not stated; completers; R0007034:Results |
All cause mortality (3 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 35 | not stated; safety; R0007034:Results | ||||
| A2 | events | 0 / 36 | not stated; safety; R0007034:Results | ||||
| A3 | events | 0 / 36 | not stated; safety; R0007034:Results |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 35 | not stated; safety; R0007034:Table 4 | ||||
| A2 | events | 1 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A3 | events | 1 / 36 | not stated; safety; R0007034:Table 4 |
Nausea (3 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 35 | not stated; safety; R0007034:Table 4 | ||||
| A2 | events | 3 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A3 | events | 7 / 36 | not stated; safety; R0007034:Table 4 |
Vomiting (3 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 35 | not stated; safety; R0007034:Table 4 | ||||
| A2 | events | 1 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A3 | events | 2 / 36 | not stated; safety; R0007034:Table 4 |
Diarrhea (3 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 35 | not stated; safety; R0007034:Table 4 | ||||
| A2 | events | 0 / 36 | not stated; safety; R0007034:Table 4 | ||||
| A3 | events | 1 / 36 | not stated; safety; R0007034:Table 4 |
Death by suicide (3 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 35 | not stated; safety; R0007034:Results | ||||
| A2 | events | 0 / 36 | not stated; safety; R0007034:Results | ||||
| A3 | events | 0 / 36 | not stated; safety; R0007034:Results |