parallel randomized trial
NCT02962492
An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo Arm | insulin titrated in all groups; lifestyle: not reported | 13 | 11 | |
| A2 | Dapagliflozin Dapagliflozin Arm | insulin titrated in all groups; lifestyle: not reported | 17 | 15 | |
| A3 | exenatide extended release Exenatide Extended Release Arm | insulin titrated in all groups; lifestyle: not reported | 17 | 15 | |
| A4 | exenatide extended release and dapagliflozin Exenatide Extended Release and Dapagliflozin Arm | insulin titrated in all groups; lifestyle: not reported | 23 | 21 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Dapagliflozin A2 | Exenatide Extended Release Arm A3 | Exenatide Extended Release and Dapagliflozin Arm A4 |
|---|---|---|---|---|---|
| age | mean (years) | 46.2 | 50.5 | 46.5 | 44.1 |
| bmi | mean (kg/m2) | 30.8 | 28.1 | 31.4 | 30.7 |
| female | n | 6 | 7 | 7 | 11 |
| hba1c | mean (percent) | 7.7 | 7.6 | 7.5 | 7.9 |
| insulin dose | mean (U/kg/day) | 0.42 | 0.40 | 0.41 | 0.37 |
| weight | mean (kg) | 85.3 | 82.6 | 91.0 | 91.0 |
Analyses this trial contributes to
- HbA1c changeType 1 diabetes; weeks 12 to 40 (target week 26); network meta-analysis
- HbA1c changeType 1 diabetes; weeks 12 to 40 (target week 26); network meta-analysis
- Total daily insulin dose changeType 1 diabetes; weeks 12 to 40 (target week 26); network meta-analysis
- Total daily insulin dose changeType 1 diabetes; weeks 12 to 40 (target week 26); network meta-analysis
- Serious adverse eventsType 1 diabetes; longest follow-up; network meta-analysis
- Serious adverse eventsType 1 diabetes; longest follow-up; network meta-analysis
- Death by suicideType 1 diabetes; longest follow-up; descriptive only
- Death by suicideType 1 diabetes; longest follow-up; descriptive only
Results
36 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (4 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | -0.1 percent | 0.1 | 11 | not stated; other; registry:outcomes | |
| 12 | A2 | change | -0.3 percent | 0.1 | 15 | not stated; other; registry:outcomes | |
| 12 | A3 | change | -0.4 percent | 0.2 | 15 | not stated; other; registry:outcomes | |
| 12 | A4 | change | -0.9 percent | 0.1 | 21 | not stated; other; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (8 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A2 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A3 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A3 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A4 | events | 0 / 21 | not stated; safety; registry:adverse_events |
Total daily insulin dose change (4 lines; O06)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 12 | A1 | change | -0.01 U/kg/day | 0.02 | 11 | not stated; other; registry:outcomes | |
| 12 | A2 | change | -0.02 U/kg/day | 0.02 | 15 | not stated; other; registry:outcomes | |
| 12 | A3 | change | -0.05 U/kg/day | 0.02 | 15 | not stated; other; registry:outcomes | |
| 12 | A4 | change | -0.04 U/kg/day | 0.02 | 21 | not stated; other; registry:outcomes |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 21 | not stated; safety; registry:adverse_events |
Diabetic ketoacidosis (8 lines; O30)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A1 | events | 0 / 11 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A2 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A3 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / | not stated; other; R0014380:Abstract | ||||
| A4 | events | 0 / 21 | not stated; safety; registry:adverse_events |
Severe hypoglycemia (type 1 diabetes) (4 lines; O31)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 21 | not stated; safety; registry:adverse_events |
Death by suicide (4 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 11 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 15 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 21 | not stated; safety; registry:adverse_events |