parallel randomized trial
EGO
The Effect of Dose Titration of LY2189265 in Overweight and Obese Patients With Type 2 Diabetes Mellitus
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Dulaglutide 2.0 mg injection once weekly Dulaglutide 1.0/2.0 mg | two oral glucose lowering drugs; lifestyle: not reported | 65 | 62 | |
| A2 | dulaglutide Dulaglutide 1.0/1.0 mg | two oral glucose lowering drugs; lifestyle: not reported | 65 | 63 | |
| A3 | dulaglutide Dulaglutide 0.5/1.0 mg | two oral glucose lowering drugs; lifestyle: not reported | 66 | 65 | |
| A4 | Placebo Placebo | two oral glucose lowering drugs; lifestyle: not reported | 66 | 65 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Dulaglutide 2.0 mg injection once weekly A1 | Dulaglutide 1.0/1.0 mg A2 | Dulaglutide 0.5/1.0 mg A3 | Placebo A4 |
|---|---|---|---|---|---|
| age | mean (years) | 54.49 | 57.46 | 58.65 | 55.96 |
| age | sd (years) | 11.28 | 11.72 | 11.69 | 12.49 |
| asian | n | 1 | 0 | 0 | 0 |
| black | n | 4 | 6 | 5 | 4 |
| bmi | mean (kg/m2) | 34.24 | 33.85 | 33.70 | 33.89 |
| bmi | sd (kg/m2) | 4.11 | 3.95 | 4.11 | 4.31 |
| diabetes duration | mean (years) | 8.63 | 8.13 | 8.97 | 7.48 |
| diabetes duration | sd (years) | 6.92 | 5.43 | 7.62 | 5.41 |
| female | n | 31 | 30 | 31 | 37 |
| hba1c | mean (percent) | 8.43 | 8.25 | 8.25 | 8.05 |
| hba1c | sd (percent) | 0.99 | 0.99 | 0.89 | 0.82 |
| hispanic | n | 23 | 20 | 19 | 26 |
| other native american | n | 1 | 0 | 2 | 0 |
| weight | mean (kg) | 98.60 | 96.68 | 94.76 | 94.74 |
| weight | sd (kg) | 18.41 | 16.51 | 16.53 | 15.21 |
| white | n | 36 | 39 | 40 | 36 |
Analyses this trial contributes to
- 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
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 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
44 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 |
|---|---|---|---|---|---|---|---|
| 16 | A1 | change | -1.52 percent | 0.12 | 62 | not stated; modified itt; registry:outcomes | |
| 16 | A2 | change | -1.29 percent | 0.12 | 63 | not stated; modified itt; registry:outcomes | |
| 16 | A3 | change | -1.28 percent | 0.12 | 65 | not stated; modified itt; registry:outcomes | |
| 16 | A4 | change | -0.27 percent | 0.12 | 65 | not stated; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (4 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 16 | A1 | change | -2.51 kg | 0.38 | 63 | not stated; modified itt; registry:outcomes | |
| 16 | A2 | change | -1.40 kg | 0.38 | 63 | not stated; modified itt; registry:outcomes | |
| 16 | A3 | change | -1.58 kg | 0.37 | 65 | not stated; modified itt; registry:outcomes | |
| 16 | A4 | change | -0.07 kg | 0.38 | 65 | not stated; modified itt; registry:outcomes |
HbA1c below 7 percent (4 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 16 | A1 | responders | 53.8 | 65 | not stated; modified itt; registry:outcomes | ||
| 16 | A2 | responders | 50.8 | 65 | not stated; modified itt; registry:outcomes | ||
| 16 | A3 | responders | 56.1 | 66 | not stated; modified itt; registry:outcomes | ||
| 16 | A4 | responders | 15.2 | 66 | not stated; modified itt; registry:outcomes |
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 65 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 65 | not stated; safety; registry:outcomes | ||||
| A3 | events | 0 / 66 | not stated; safety; registry:outcomes | ||||
| A4 | events | 0 / 66 | not stated; safety; registry:outcomes |
Serious adverse events (4 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 65 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 2 / 65 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 66 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 1 / 66 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (4 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 65 | not stated; randomized; registry:flow | ||||
| A2 | events | 4 / 65 | not stated; randomized; registry:flow | ||||
| A3 | events | 3 / 66 | not stated; randomized; registry:flow | ||||
| A4 | events | 1 / 66 | not stated; randomized; registry:flow |
Nausea (4 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 65 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 11 / 65 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 9 / 66 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 5 / 66 | not stated; safety; registry:adverse_events |
Vomiting (4 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 65 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 65 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 3 / 66 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 2 / 66 | not stated; safety; registry:adverse_events |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 65 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 4 / 65 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 5 / 66 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 5 / 66 | not stated; safety; registry:adverse_events |
Constipation (4 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 65 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 65 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 6 / 66 | not stated; safety; registry:adverse_events | ||||
| A4 | events | 0 / 66 | not stated; safety; registry:adverse_events |
Acute pancreatitis (4 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 65 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A2 | events | 0 / 65 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A3 | events | 1 / 66 | not stated; safety; pancreatitis; registry:adverse_events | ||||
| A4 | events | 0 / 66 | not stated; safety; pancreatitis; registry:adverse_events |