parallel randomized trial
NCT00395746
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 0.6 mg subcutaneous once daily Liraglutide 0.6 mg plus SU | sulfonylurea (glimepiride, glibenclamide or gliclazide); lifestyle: not reported | 89 | 86 | |
| A2 | Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg plus SU | sulfonylurea (glimepiride, glibenclamide or gliclazide); lifestyle: not reported | 89 | 87 | |
| A3 | Placebo Placebo plus SU | sulfonylurea (glimepiride, glibenclamide or gliclazide); lifestyle: not reported | 89 | 88 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 0.6 mg subcutaneous once daily A1 | Liraglutide 0.9 mg injection once daily A2 | Placebo A3 |
|---|---|---|---|---|
| age | mean (years) | 59.1 | 61.3 | 58.6 |
| age | sd (years) | 10.3 | 11.0 | 9.7 |
| bmi | mean (kg/m2) | 25.3 | 24.4 | 24.9 |
| bmi | sd (kg/m2) | 3.6 | 3.8 | 4.0 |
| diabetes duration | mean (years) | 9.3 | 11.6 | 10.1 |
| diabetes duration | sd (years) | 5.8 | 7.7 | 7.3 |
| female | n | 35 | 29 | 31 |
| female | percent | 39.8 | 33.0 | 35.2 |
| hba1c | mean (percent) | 9.00 | 8.61 | 8.85 |
| hba1c | sd (percent) | 0.91 | 0.78 | 0.99 |
| waist | mean (cm) | 88.0 | 86.4 | 88.1 |
| waist | sd (cm) | 8.8 | 9.2 | 10.2 |
| weight | mean (kg) | 66.2 | 64.5 | 66.8 |
| weight | sd (kg) | 12.0 | 12.0 | 13.7 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); longest follow-up; network meta-analysis
- Level 2 or 3 hypoglycemia (participants)Type 2 diabetes (adults); 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
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); 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
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
50 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (13 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | final | 7.02 percent | 0.10 | 86 | not stated; full analysis; registry:outcomes | |
| 24 | A1 vs A3 | md | -1.00 percent | -1.24 to -0.75 | not stated; full analysis; registry:outcomes | ||
| 24 | A2 | final | 6.75 percent | 0.11 | 87 | not stated; full analysis; registry:outcomes | |
| 24 | A2 vs A3 | md | -1.27 percent | -1.51 to 1.02 | not stated; full analysis; registry:outcomes | ||
| 24 | A3 | final | 8.02 percent | 0.10 | 88 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | final | 7.8 percent | 0.1 | 86 | not stated; full analysis; R0022802:Table 2 | |
| 52 | A1 | final | 7.42 percent | 0.12 | 86 | not stated; full analysis; registry:outcomes | |
| 52 | A1 vs A3 | md | -0.96 percent | -1.25 to -0.67 | not stated; full analysis; R0022802:Table 2 | ||
| 52 | A2 | final | 7.5 percent | 0.1 | 87 | not stated; full analysis; R0022802:Table 2 | |
| 52 | A2 | final | 7.06 percent | 0.13 | 87 | not stated; full analysis; registry:outcomes | |
| 52 | A2 vs A3 | md | -1.33 percent | -1.62 to -1.04 | not stated; full analysis; R0022802:Table 2 | ||
| 52 | A3 | final | 8.8 percent | 0.1 | 88 | not stated; full analysis; R0022802:Table 2 | |
| 52 | A3 | final | 8.39 percent | 0.12 | 88 | not stated; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (10 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | final | 65.77 kg | 0.23 | 87 | not stated; full analysis; registry:outcomes | |
| 24 | A1 vs A3 | md | 1.18 kg | 0.63 to 1.73 | not stated; full analysis; registry:outcomes | ||
| 24 | A2 | final | 65.34 kg | 0.24 | 87 | not stated; full analysis; registry:outcomes | |
| 24 | A2 vs A3 | md | 0.75 kg | 0.21 to 1.30 | not stated; full analysis; registry:outcomes | ||
| 24 | A3 | final | 64.59 kg | 0.23 | 88 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | final | 65.96 kg | 0.26 | 87 | not stated; full analysis; registry:outcomes | |
| 52 | A1 vs A3 | md | 1.13 kg | 0.51 to 1.75 | not stated; full analysis; registry:outcomes | ||
| 52 | A2 | final | 65.87 kg | 0.27 | 87 | not stated; full analysis; registry:outcomes | |
| 52 | A2 vs A3 | md | 1.04 kg | 0.42 to 1.66 | not stated; full analysis; registry:outcomes | ||
| 52 | A3 | final | 64.83 kg | 0.26 | 88 | not stated; full analysis; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (3 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 88 | not stated; safety; R0022802:Results | ||||
| A2 | events | 0 / 88 | not stated; safety; R0022802:Results | ||||
| A3 | events | 0 / 88 | not stated; safety; R0022802:Results |
All cause mortality (3 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 88 | not stated; safety; R0022802:Results | ||||
| A2 | events | 0 / 88 | not stated; safety; R0022802:Results | ||||
| A3 | events | 0 / 88 | not stated; safety; R0022802:Results |
Serious adverse events (3 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 88 | not stated; safety; R0022802:Results | ||||
| A2 | events | 3 / 88 | not stated; safety; R0022802:Results | ||||
| A3 | events | 5 / 88 | not stated; safety; R0022802:Results |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 88 | not stated; safety; R0022802:Results | ||||
| A2 | events | 2 / 88 | not stated; safety; R0022802:Results | ||||
| A3 | events | 2 / 88 | not stated; safety; R0022802:Results |
Diarrhea (3 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 88 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 14 / 88 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 7 / 88 | not stated; safety; registry:adverse_events |
Constipation (3 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 88 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 11 / 88 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 4 / 88 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (3 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 88 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 88 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 1 / 88 | not stated; safety; cholecystitis; registry:adverse_events |
Acute pancreatitis (3 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 88 | not stated; safety; R0022802:Results | ||||
| A2 | events | 0 / 88 | not stated; safety; R0022802:Results | ||||
| A3 | events | 0 / 88 | not stated; safety; R0022802:Results |
Diabetic retinopathy complications (3 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 8 / 88 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 11 / 88 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A3 | events | 7 / 88 | not stated; safety; diabetic retinopathy; registry:adverse_events |