crossover randomized trial
NCT02745470
Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain Measured by Functional MRI
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | lixisenatide Lixisenatide 10 ug single injection | lifestyle: not reported | 30 | 29 | |
| A2 | Placebo Normal saline injection | lifestyle: not reported | 30 | 29 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Lixisenatide 10 ug single injection A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age bmi:less_than_23 | mean (years) | 61.6 | ||
| age bmi:less_than_23 | sd (years) | 4.5 | ||
| age bmi:more_than_26 | mean (years) | 59.4 | ||
| age bmi:more_than_26 | sd (years) | 5.9 | ||
| bmi bmi:less_than_23 | mean (kg/m2) | 21.9 | ||
| bmi bmi:less_than_23 | sd (kg/m2) | 0.8 | ||
| bmi bmi:more_than_26 | mean (kg/m2) | 28.1 | ||
| bmi bmi:more_than_26 | sd (kg/m2) | 2.2 | ||
| diabetes duration bmi:less_than_23 | mean (years) | 10.2 | ||
| diabetes duration bmi:less_than_23 | sd (years) | 5.2 | ||
| diabetes duration bmi:more_than_26 | mean (years) | 8.1 | ||
| diabetes duration bmi:more_than_26 | sd (years) | 4.7 | ||
| egfr bmi:less_than_23 | mean (mL/min/1.73 m2) | 94.4 | ||
| egfr bmi:less_than_23 | sd (mL/min/1.73 m2) | 14.6 | ||
| egfr bmi:more_than_26 | mean (mL/min/1.73 m2) | 91.8 | ||
| egfr bmi:more_than_26 | sd (mL/min/1.73 m2) | 18.2 | ||
| hba1c bmi:less_than_23 | mean (percent) | 6.7 | ||
| hba1c bmi:less_than_23 | sd (percent) | 0.5 | ||
| hba1c bmi:more_than_26 | mean (percent) | 6.8 | ||
| hba1c bmi:more_than_26 | sd (percent) | 0.4 | ||
| metformin use bmi:less_than_23 | n | 14 | ||
| metformin use bmi:more_than_26 | n | 13 |
Results
8 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 34.5 | 29 | not stated; modified itt; R0010214:Results | |||
| A2 | events | 20.7 | 29 | not stated; modified itt; R0010214:Results |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 29 | not stated; modified itt; R0010214:Results | ||||
| A2 | events | 0 / 29 | not stated; modified itt; R0010214:Results |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 29 | not stated; modified itt; R0010214:Results | ||||
| A2 | events | 0 / 29 | not stated; modified itt; R0010214:Results |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 29 | not stated; modified itt; R0010214:Results | ||||
| A2 | events | 0 / 29 | not stated; modified itt; R0010214:Results |