parallel randomized trial
S003032
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Standard care or no added treatment Intragastric balloon only | Spatz3 intragastric balloon for 6 months; staged diet; lifestyle: intensive | 25 | 20 | |
| A2 | Semaglutide 1.0 mg subcutaneous once weekly Intragastric balloon plus semaglutide | Spatz3 intragastric balloon for 6 months; staged diet; lifestyle: intensive | 25 | 20 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Standard care or no added treatment A1 | Semaglutide 1.0 mg subcutaneous once weekly A2 |
|---|---|---|---|
| age | mean (years) | 36.90 | 36.20 |
| age | sd (years) | 9.16 | 8.43 |
| bmi | mean (kg/m2) | 38.75 | 39.36 |
| bmi | sd (kg/m2) | 1.45 | 1.88 |
| female | n | 13 | 14 |
| female | percent | 65.0 | 70.0 |
| other diabetes | n | 6 | 4 |
| other diabetes | percent | 30.0 | 20.0 |
| weight | mean (kg) | 115.8 | 117.1 |
| weight | sd (kg) | 9.94 | 9.73 |
Analyses this trial contributes to
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Percent body weight changeOverweight or obesity without diabetes (adults); weeks 40 to 104 (target week 68); network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to gastrointestinal adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to gastrointestinal adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; descriptive only
Results
10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (2 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52.14 | A1 | percent change | -13.47 percent | 2.06 | 20 | not stated; completers; R0015729:Table 4 | |
| 52.14 | A2 | percent change | -28.21 percent | 2.11 | 20 | not stated; completers; R0015729:Table 4 |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; completers; R0015729:Table 2 | ||||
| A2 | events | 0 / 20 | not stated; completers; R0015729:Table 2 |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; completers; R0015729:Table 2 | ||||
| A2 | events | 0 / 20 | not stated; completers; R0015729:Table 2 |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 20 | not stated; completers; nausea & vomiting; R0015729:Table 2 | ||||
| A2 | events | 10 / 20 | not stated; completers; nausea & vomiting; R0015729:Table 2 |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; completers; R0015729:Table 2 | ||||
| A2 | events | 0 / 20 | not stated; completers; R0015729:Table 2 |