parallel randomized trial
NCT01620489
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 1.8 mg subcutaneous once daily Lira 1.8 mg | existing oral glucose lowering drugs and/or insulin; lifestyle: not reported | 140 | 127 | |
| A2 | Placebo Placebo | existing oral glucose lowering drugs and/or insulin; lifestyle: not reported | 139 | 136 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 1.8 mg subcutaneous once daily A1 | Placebo A2 |
|---|---|---|---|
| age | mean (years) | 68.0 | 66.3 |
| age | sd (years) | 8.3 | 8.0 |
| diabetes duration | mean (years) | 15.6 | 14.3 |
| diabetes duration | sd (years) | 8.9 | 7.6 |
| female | n | 65 | 72 |
| hba1c | mean (percent) | 8.08 | 8.00 |
| hba1c | sd (percent) | 0.792 | 0.853 |
Analyses this trial contributes to
- Serious adverse eventsChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- Serious adverse eventsChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- NauseaChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- DiarrheaChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- ConstipationChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- ConstipationChronic kidney disease with diabetes; longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
- ConstipationType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
17 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (3 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.05 percent | 0.8944 | 127 | not stated; full analysis; registry:outcomes | |
| 26 | A1 vs A2 | md | -0.66 percent | -0.90 to -0.43 | not stated; full analysis; registry:outcomes | ||
| 26 | A2 | change | -0.38 percent | 0.8797 | 136 | not stated; full analysis; registry:outcomes |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 14 / 140 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 15 / 137 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 17 / 140 | not stated; randomized; registry:flow | ||||
| A2 | events | 4 / 139 | not stated; randomized; registry:flow |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 30 / 140 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 6 / 137 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 17 / 140 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 137 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 10 / 140 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 137 | not stated; safety; registry:adverse_events |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 140 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 137 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (2 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 140 | not stated; safety; Cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 137 | not stated; safety; Cholecystitis; registry:adverse_events |