parallel randomized trial
DUAL™ VIII
A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated IDegLira plus OADs | oral antidiabetic drugs continued; lifestyle: not reported | 506 | 506 | |
| A2 | Insulin glargine Insulin glargine U100 plus OADs | oral antidiabetic drugs continued; lifestyle: not reported | 506 | 506 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Insulin degludec and liraglutide (IDegLira) subcutaneous once daily titrated A1 | Insulin glargine A2 |
|---|---|---|---|
| age | mean (years) | 56.8 | 56.4 |
| age | sd (years) | 10.0 | 10.1 |
| asian | n | 54 | 61 |
| black | n | 25 | 28 |
| bmi | mean (kg/m2) | 32.1 | 31.4 |
| bmi | sd (kg/m2) | 6.5 | 5.2 |
| diabetes duration | mean (years) | 9.8 | 10.1 |
| diabetes duration | sd (years) | 5.7 | 5.5 |
| female | n | 226 | 231 |
| hba1c | mean (percent) | 8.2 | 8.2 |
| hba1c | sd (percent) | 0.9 | 0.9 |
| hispanic | n | 115 | 126 |
| other race other | n | 3 | 3 |
| white | n | 424 | 414 |
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
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 64 to 130 (target week 104); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- 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
- HbA1c below 7 percentType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 64 to 130 (target week 104); descriptive only
- Systolic blood pressure changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 64 to 130 (target week 104); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); network meta-analysis
- SF-36 physical component summary changeType 2 diabetes (adults); weeks 20 to 130 (target week 52); 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
Results
69 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (5 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -2.0 percent | 506 | not stated; full analysis; R0012674:Results | ||
| 26 | A1 | change | -1.99 percent | 1.14 | 506 | not stated; full analysis; registry:outcomes | |
| 26 | A1 vs A2 | md | -0.47 percent | -0.58 to -0.36 | not stated; full analysis; R0012674:Results | ||
| 26 | A2 | change | -1.5 percent | 506 | not stated; full analysis; R0012674:Results | ||
| 26 | A2 | change | -1.69 percent | 1.10 | 506 | not stated; full analysis; registry:outcomes |
Body weight change in kilograms (diabetes) (7 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 0.5 kg | 3.3 | 506 | not stated; full analysis; registry:outcomes | |
| 26 | A1 | change | 0.5 kg | 506 | not stated; full analysis; R0012674:Results | ||
| 26 | A1 vs A2 | md | -1.57 kg | -2.00 to -1.13 | not stated; full analysis; R0012674:Results | ||
| 26 | A2 | change | 2.1 kg | 506 | not stated; full analysis; R0012674:Results | ||
| 26 | A2 | change | 2.2 kg | 3.6 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A1 | change | 1.2 kg | 4.9 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A2 | change | 3.0 kg | 4.9 | 506 | not stated; full analysis; registry:outcomes |
HbA1c below 7 percent (4 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | responders | 78.7 | 506 | not stated; full analysis; registry:outcomes | ||
| 26 | A2 | responders | 55.7 | 506 | not stated; full analysis; registry:outcomes | ||
| 104 | A1 | responders | 55.5 | 506 | not stated; full analysis; registry:outcomes | ||
| 104 | A2 | responders | 28.5 | 506 | not stated; full analysis; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 506 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 504 | not stated; safety; registry:adverse_events |
Level 2 or 3 hypoglycemia (episode rate) (1 lines; O04B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 vs A2 | rate ratio | 0.56 | 0.39 to 0.82 | not stated; safety; R0012674:Results |
Systolic blood pressure change (4 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | -1.2 mmHg | 14.0 | 506 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | 0.5 mmHg | 13.1 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A1 | change | 0.5 mmHg | 14.3 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A2 | change | 0.9 mmHg | 13.6 | 506 | not stated; full analysis; registry:outcomes |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 506 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 5 / 504 | not stated; safety; registry:adverse_events |
Hospitalization for heart failure (6 lines; O23)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 506 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A1 | events | 0 / 506 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A1 | events | 0 / 506 | not stated; safety; cardiac failure; registry:adverse_events | ||||
| A2 | events | 2 / 504 | not stated; safety; cardiac failure chronic; registry:adverse_events | ||||
| A2 | events | 2 / 504 | not stated; safety; cardiac failure congestive; registry:adverse_events | ||||
| A2 | events | 1 / 504 | not stated; safety; cardiac failure; registry:adverse_events |
SF-36 physical component summary change (4 lines; O24A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 1.6 points | 6.3 | 506 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | 0.9 points | 6.3 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A1 | change | 1.0 points | 7.2 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A2 | change | 0.8 points | 6.0 | 506 | not stated; full analysis; registry:outcomes |
Physical functioning (any instrument) (4 lines; O24B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 1.2 points | 6.8 | 506 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | 1.1 points | 7.0 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A1 | change | 0.7 points | 7.5 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A2 | change | 0.6 points | 7.9 | 506 | not stated; full analysis; registry:outcomes |
Health related quality of life total score (any instrument) (4 lines; O24C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26 | A1 | change | 9.6 points | 12.4 | 506 | not stated; full analysis; registry:outcomes | |
| 26 | A2 | change | 7.3 points | 13.1 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A1 | change | 11.4 points | 13.7 | 506 | not stated; full analysis; registry:outcomes | |
| 104 | A2 | change | 9.5 points | 12.8 | 506 | 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 | 60 / 506 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 43 / 504 | 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 | 2 / 506 | not stated; randomized; registry:flow | ||||
| A2 | events | 6 / 506 | not stated; randomized; registry:flow |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 31 / 506 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 506 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 8 / 504 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 504 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 506 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 504 | not stated; safety; registry:adverse_events |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 506 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 39 / 506 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 12 / 504 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 504 | not stated; safety; registry:adverse_events |
Gallbladder and biliary disease (6 lines; O28)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 506 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 0 / 506 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A1 | events | 2 / 506 | not stated; safety; cholelithiasis; registry:adverse_events | ||||
| A2 | events | 1 / 504 | not stated; safety; cholecystitis infective; registry:adverse_events | ||||
| A2 | events | 1 / 504 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 3 / 504 | not stated; safety; cholelithiasis; registry:adverse_events |
Acute pancreatitis (2 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 506 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A2 | events | 1 / 504 | not stated; safety; pancreatitis; registry:adverse_events |
Diabetic retinopathy complications (2 lines; O33)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 506 | not stated; safety; diabetic retinopathy; registry:adverse_events | ||||
| A2 | events | 0 / 504 | not stated; safety; diabetic retinopathy; registry:adverse_events |
Intestinal obstruction or ileus (2 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 506 | not stated; safety; small intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 504 | not stated; safety; small intestinal obstruction; registry:adverse_events |