parallel randomized trial
CRANIOEXE
Multicentre Double-blind Randomized Clinical Trial Assessing Efficacy and Safety of Exenatide in the Treatment of Hypothalamic Obesity After Craniopharyngioma Therapy
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily | hydrocortisone replacement; lifestyle: intensive | 20 | 20 | |
| A2 | Placebo Placebo twice daily | hydrocortisone replacement; lifestyle: intensive | 21 | 20 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Exenatide 10 ug subcutaneous twice daily A1 | Placebo A2 |
|---|---|---|---|
| age | mean (years) | 40.4 | 40.4 |
| age | sd (years) | 14.8 | 12.4 |
| bmi | mean (kg/m2) | 37.3 | 37.4 |
| bmi | sd (kg/m2) | 7.5 | 7.3 |
| egfr | mean (mL/min/1.73 m2) | 129 | 138 |
| egfr | sd (mL/min/1.73 m2) | 52 | 66 |
| female | n | 8 | 9 |
| female | percent | 40 | 45 |
| hba1c | mean (percent) | 5.7 | 5.7 |
| hba1c | sd (percent) | 0.6 | 0.7 |
| sbp | mean (mmHg) | 132 | 132 |
| sbp | sd (mmHg) | 12 | 16 |
| waist | mean (cm) | 123.6 | 116.9 |
| waist | sd (cm) | 21.8 | 13.8 |
| weight | mean (kg) | 109.1 | 106.1 |
| weight | sd (kg) | 19.9 | 17.4 |
Results
10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Physical functioning (any instrument) (3 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 5.0 points | 12.6 | not stated; completers; R0013451:Table 2 | ||
| 26 | A1 vs A2 | md | 4.3 points | -3.9 to 12.5 | not stated; completers; R0013451:Table 2 | ||
| 26 | A2 | change | 2.3 points | 10.0 | not stated; completers; R0013451:Table 2 |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 20 | not stated; modified itt; R0013451:Results | ||||
| A2 | events | 5 / 20 | not stated; modified itt; R0013451:Results |
Discontinuation due to adverse events (1 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 20 | not stated; randomized; R0013451:Figure 1 |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 12 / 20 | not stated; modified itt; nausea and vomiting; R0013451:Results | ||||
| A2 | events | 1 / 20 | not stated; modified itt; nausea and vomiting; R0013451:Results |
Acute pancreatitis (2 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 20 | not stated; modified itt; R0013451:Table 3 | ||||
| A2 | events | 0 / 20 | not stated; modified itt; R0013451:Table 3 |