parallel randomized trial
NCT04876027
Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg plus calorie restricted diet | calorie restricted diet 1000 to 1300 kcal with dietitian follow up and exercise advice; lifestyle: intensive | 35 | 35 | |
| A2 | Standard care or no added treatment Calorie restricted diet alone | calorie restricted diet 1000 to 1300 kcal with dietitian follow up and exercise advice; lifestyle: intensive | 33 | 33 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Dulaglutide 1.5 mg subcutaneous once weekly A1 | Standard care or no added treatment A2 |
|---|---|---|---|
| age | mean (years) | 30.31 | 28.64 |
| bmi | mean (kg/m2) | 29.68 | 29.71 |
| hba1c | mean (percent) | 5.72 | 5.64 |
| sbp | mean (mmHg) | 124.14 | 127.69 |
| waist | mean (cm) | 96.76 | 94.89 |
| weight | mean (kg) | 77.62 | 78.84 |
Analyses this trial contributes to
- Discontinuation due to adverse eventsPolycystic ovary syndrome; longest follow-up; descriptive only
- Discontinuation due to adverse eventsPolycystic ovary syndrome; longest follow-up; descriptive only
- NauseaPolycystic ovary syndrome; longest follow-up; network meta-analysis
- NauseaPolycystic ovary syndrome; longest follow-up; network meta-analysis
- VomitingPolycystic ovary syndrome; longest follow-up; descriptive only
- VomitingPolycystic ovary syndrome; longest follow-up; descriptive only
- DiarrheaPolycystic ovary syndrome; longest follow-up; network meta-analysis
- DiarrheaPolycystic ovary syndrome; longest follow-up; network meta-analysis
- ConstipationPolycystic ovary syndrome; longest follow-up; descriptive only
- ConstipationPolycystic ovary syndrome; longest follow-up; descriptive only
- Discontinuation due to gastrointestinal adverse eventsPolycystic ovary syndrome; longest follow-up; descriptive only
- Discontinuation due to gastrointestinal adverse eventsPolycystic ovary syndrome; longest follow-up; descriptive only
Results
12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 35 | not stated; randomized; R0009547:Table 3 | ||||
| A2 | events | 0 / 33 | not stated; randomized; R0009547:Table 3 |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 35 | not stated; randomized; R0009547:Table 3 | ||||
| A2 | events | 0 / 33 | not stated; randomized; R0009547:Table 3 |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 35 | not stated; randomized; R0009547:Table 3 | ||||
| A2 | events | 0 / 33 | not stated; randomized; R0009547:Table 3 |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 35 | not stated; randomized; R0009547:Table 3 | ||||
| A2 | events | 0 / 33 | not stated; randomized; R0009547:Table 3 |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 35 | not stated; randomized; R0009547:Table 3 | ||||
| A2 | events | 0 / 33 | not stated; randomized; R0009547:Table 3 |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 35 | not stated; randomized; R0009547:Results | ||||
| A2 | events | 0 / 33 | not stated; randomized; R0009547:Table 3 |