parallel randomized trial
NCT00393718
Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg | none (glibenclamide placebo); lifestyle: not reported | 272 | 263 | |
| A2 | Glibenclamide Glibenclamide 1.25 to 2.5 mg | none; OADs prohibited; lifestyle: not reported | 139 | 130 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 0.9 mg injection once daily A1 | Glibenclamide A2 |
|---|---|---|---|
| age | mean (years) | 58.2 | 58.5 |
| age | sd (years) | 10.4 | 10.4 |
| bmi | mean (kg/m2) | 24.9 | 24.6 |
| bmi | sd (kg/m2) | 3.7 | 3.8 |
| diabetes duration | mean (years) | 8.1 | 8.5 |
| diabetes duration | sd (years) | 6.7 | 6.8 |
| female | n | 85 | 46 |
| female | percent | 31.7 | 34.8 |
| hba1c | mean (percent) | 9.32 | 9.18 |
| hba1c | sd (percent) | 1.08 | 0.97 |
| other prior oad | n | 218 | 109 |
| other prior oad | percent | 81.3 | 82.6 |
| weight | mean (kg) | 66.2 | 65.4 |
| weight | sd (kg) | 12.6 | 12.9 |
Analyses this trial contributes to
- 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
- 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
- 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 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 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
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 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
Results
57 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (8 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 vs A2 | md | -0.50 percent | -0.70 to -0.30 | not stated; full analysis; registry:outcomes | ||
| 24 | A1 | final | 6.99 percent | 0.07 | 263 | not stated; full analysis; registry:outcomes | |
| 24 | A2 | final | 7.50 percent | 0.09 | 130 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | final | 7.7 percent | 0.1 | 263 | not stated; full analysis; R0022766:Table 2 | |
| 52 | A1 | final | 7.31 percent | 0.08 | 263 | not stated; full analysis; registry:outcomes | |
| 52 | A1 vs A2 | md | -0.49 percent | -0.71 to -0.27 | not stated; full analysis; R0022766:Table 2 | ||
| 52 | A2 | final | 8.2 percent | 0.1 | 130 | not stated; full analysis; R0022766:Table 2 | |
| 52 | A2 | final | 7.80 percent | 0.10 | 130 | not stated; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (11 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | final | 64.06 kg | 0.15 | 265 | not stated; full analysis; registry:outcomes | |
| 24 | A1 vs A2 | md | -1.91 kg | -2.34 to -1.48 | not stated; full analysis; registry:outcomes | ||
| 24 | A2 | final | 65.97 kg | 0.20 | 130 | not stated; full analysis; registry:outcomes | |
| 52 | A1 | final | 64.30 kg | 0.19 | 265 | not stated; full analysis; registry:outcomes | |
| 52 | A1 vs A2 | md | -1.7 kg | -2.3 to -1.2 | not stated; full analysis; R0022766:Results | ||
| 52 | A1 vs A2 | md | -1.71 kg | -2.25 to -1.18 | not stated; full analysis; registry:outcomes | ||
| 52 | A1 | change | -1.05 kg | not stated; full analysis; bmi:>=25; R0022766:Results | |||
| 52 | A1 | change | -0.51 kg | not stated; full analysis; bmi:<25; R0022766:Results | |||
| 52 | A2 | final | 66.01 kg | 0.25 | 130 | not stated; full analysis; registry:outcomes | |
| 52 | A2 | change | 1.05 kg | not stated; full analysis; bmi:<25; R0022766:Results | |||
| 52 | A2 | change | 0.84 kg | not stated; full analysis; bmi:>=25; R0022766:Results |
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 268 | not stated; safety; R0022766:Results | ||||
| A2 | events | 0 / 132 | not stated; safety; R0022766:Results |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 268 | not stated; safety; R0022766:Results | ||||
| A2 | events | 0 / 132 | not stated; safety; R0022766:Results |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 20 / 268 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 14 / 132 | 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 | 20 / 268 | not stated; randomized; registry:flow | ||||
| A2 | events | 8 / 132 | not stated; randomized; registry:flow |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 14 / 268 | not stated; safety; R0022766:Table 4 | ||||
| A2 | events | 2 / 132 | not stated; safety; R0022766:Table 4 |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 268 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 132 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 26 / 268 | not stated; safety; R0022766:Table 4 | ||||
| A2 | events | 9 / 132 | not stated; safety; R0022766:Table 4 |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 22 / 268 | not stated; safety; R0022766:Table 4 | ||||
| A2 | events | 7 / 132 | not stated; safety; R0022766:Table 4 |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 5 / 268 | not stated; safety; R0022766:Results | ||||
| A2 | events | 3 / 132 | not stated; safety; R0022766:Results |
Gallbladder and biliary disease (2 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 268 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 1 / 132 | not stated; safety; cholelithiasis; registry:adverse_events |
Diabetic retinopathy complications (2 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 16 / 268 | not stated; safety; diabetic retinopathy; R0022766:Table 4 | ||||
| A2 | events | 9 / 132 | not stated; safety; diabetic retinopathy; R0022766:Table 4 |
Suicidal ideation or behavior (2 lines; O35A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 268 | not stated; safety; suicide attempt; registry:adverse_events | ||||
| A2 | events | 1 / 132 | not stated; safety; suicide attempt; registry:adverse_events |
Any cancer (14 lines; O39)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 268 | not stated; safety; gastric cancer; registry:adverse_events | ||||
| A1 | events | 0 / 268 | not stated; safety; laryngeal cancer; registry:adverse_events | ||||
| A1 | events | 0 / 268 | not stated; safety; metastatic neoplasm; registry:adverse_events | ||||
| A1 | events | 1 / 268 | not stated; safety; multiple myeloma; registry:adverse_events | ||||
| A1 | events | 1 / 268 | not stated; safety; prostate cancer; registry:adverse_events | ||||
| A1 | events | 1 / 268 | not stated; safety; rectal cancer; registry:adverse_events | ||||
| A1 | events | 1 / 268 | not stated; safety; renal cell carcinoma; registry:adverse_events | ||||
| A2 | events | 0 / 132 | not stated; safety; gastric cancer; registry:adverse_events | ||||
| A2 | events | 1 / 132 | not stated; safety; laryngeal cancer; registry:adverse_events | ||||
| A2 | events | 1 / 132 | not stated; safety; metastatic neoplasm; registry:adverse_events | ||||
| A2 | events | 0 / 132 | not stated; safety; multiple myeloma; registry:adverse_events | ||||
| A2 | events | 0 / 132 | not stated; safety; prostate cancer; registry:adverse_events | ||||
| A2 | events | 0 / 132 | not stated; safety; rectal cancer; registry:adverse_events | ||||
| A2 | events | 0 / 132 | not stated; safety; renal cell carcinoma; registry:adverse_events |