parallel randomized trial
GETGOAL-F1
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, 24-week Study Followed by an Extension Assessing the Efficacy and Safety of AVE0010 in Two Titration Regimens on Top of Metformin in Patients With Type 2 Diabetes Not Adequately Controlled With Metformin
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo (one-step and two-step titration combined) | metformin; lifestyle: not reported | 158 | ||
| A2 | Lixisenatide 20 ug subcutaneous once daily Lixisenatide two step titration | metformin; lifestyle: not reported | 161 | 152 | |
| A3 | Lixisenatide 20 ug subcutaneous once daily Lixisenatide one step titration | metformin; lifestyle: not reported | 161 | 156 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Lixisenatide 20 ug subcutaneous once daily A2 | Lixisenatide 20 ug subcutaneous once daily A3 | Whole trial ALL |
|---|---|---|---|---|---|
| age titration:one_step_placebo | mean (years) | 57.5 | |||
| age titration:one_step_placebo | sd (years) | 10.8 | |||
| age titration:two_step_placebo | mean (years) | 58.9 | |||
| age titration:two_step_placebo | sd (years) | 8.8 | |||
| age | mean (years) | 54.6 | 55.4 | 56.1 | |
| age | sd (years) | 8.9 | 8.9 | 9.3 | |
| asian | n | 11 | 13 | 33 | |
| black | n | 2 | 1 | 4 | |
| bmi titration:one_step_placebo | mean (kg/m2) | 32.35 | |||
| bmi titration:one_step_placebo | sd (kg/m2) | 5.86 | |||
| bmi titration:two_step_placebo | mean (kg/m2) | 32.38 | |||
| bmi titration:two_step_placebo | sd (kg/m2) | 5.04 | |||
| bmi | mean (kg/m2) | 32.06 | 32.99 | 32.47 | |
| bmi | sd (kg/m2) | 4.84 | 5.80 | 5.38 | |
| diabetes duration | mean (years) | 6.01 | 5.77 | 6.00 | |
| diabetes duration | sd (years) | 4.60 | 3.85 | 4.40 | |
| female titration:one_step_placebo | n | 45 | |||
| female titration:two_step_placebo | n | 43 | |||
| female | n | 89 | 90 | 267 | |
| hba1c titration:one_step_placebo | mean (percent) | 8.02 | |||
| hba1c titration:one_step_placebo | sd (percent) | 0.84 | |||
| hba1c titration:two_step_placebo | mean (percent) | 8.03 | |||
| hba1c titration:two_step_placebo | sd (percent) | 0.81 | |||
| hba1c | mean (percent) | 8.10 | 7.99 | 8.04 | |
| hba1c | sd (percent) | 0.88 | 0.87 | 0.86 | |
| hispanic | n | 55 | 44 | 145 | |
| weight titration:one_step_placebo | mean (kg) | 88.28 | |||
| weight titration:one_step_placebo | sd (kg) | 18.43 | |||
| weight titration:two_step_placebo | mean (kg) | 87.45 | |||
| weight titration:two_step_placebo | sd (kg) | 16.32 | |||
| weight | mean (kg) | 87.41 | 90.21 | 88.50 | |
| weight | sd (kg) | 16.90 | 18.95 | 17.77 | |
| white | n | 146 | 141 | 435 |
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 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 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
- 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
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); network meta-analysis
- Weight loss of 5 percent or moreType 2 diabetes (adults); weeks 20 to 40 (target week 26); 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
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 | change | -0.42 percent | 0.099 | 158 | not stated; modified itt; registry:outcomes | |
| 24 | A1 | change | -0.40 percent | 0.85 | 158 | not stated; modified itt; R0021439:Supplement Table 1 | |
| 24 | A2 | change | -0.83 percent | 0.099 | 152 | not stated; modified itt; registry:outcomes | |
| 24 | A2 | change | -0.85 percent | 0.93 | 152 | not stated; modified itt; R0021439:Supplement Table 1 | |
| 24 | A2 vs A1 | md | -0.41 percent | -0.583 to -0.232 | not stated; modified itt; registry:outcomes | ||
| 24 | A3 | change | -0.92 percent | 0.101 | 156 | not stated; modified itt; registry:outcomes | |
| 24 | A3 | change | -0.86 percent | 0.86 | 156 | not stated; modified itt; R0021439:Supplement Table 1 | |
| 24 | A3 vs A1 | md | -0.49 percent | -0.670 to -0.317 | not stated; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -1.63 kg | 0.385 | 158 | not stated; modified itt; registry:outcomes | |
| 24 | A2 | change | -2.68 kg | 0.385 | 155 | not stated; modified itt; registry:outcomes | |
| 24 | A3 | change | -2.63 kg | 0.389 | 158 | not stated; modified itt; registry:outcomes |
HbA1c below 7 percent (3 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 38 / 158 | not stated; modified itt; R0021439:Supplement Table 2 | |||
| 24 | A2 | responders | 64 / 152 | not stated; modified itt; R0021439:Supplement Table 2 | |||
| 24 | A3 | responders | 74 / 156 | not stated; modified itt; R0021439:Supplement Table 2 |
Level 2 or 3 hypoglycemia (participants) (3 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 160 | not stated; safety; registry:outcomes | ||||
| A2 | events | 0 / 161 | not stated; safety; registry:outcomes | ||||
| A3 | events | 0 / 161 | not stated; safety; registry:outcomes |
Weight loss of 5 percent or more (3 lines; O11A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | responders | 15.2 | 158 | not stated; modified itt; registry:outcomes | ||
| 24 | A2 | responders | 25.8 | 155 | not stated; modified itt; registry:outcomes | ||
| 24 | A3 | responders | 19.6 | 158 | not stated; modified itt; registry:outcomes |
All cause mortality (1 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 2 / 160 | not stated; safety; R0021439:Supplement Table 4 |
Serious adverse events (3 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 22 / 160 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 21 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 16 / 161 | not stated; safety; registry:adverse_events |
Discontinuation due to adverse events (3 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 160 | not stated; safety; R0021439:Supplement Table 4 | ||||
| A2 | events | 19 / 161 | not stated; randomized; registry:flow | ||||
| A3 | events | 14 / 161 | not stated; randomized; registry:flow |
Nausea (6 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 13 / 160 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 160 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 61 / 161 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 47 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 161 | not stated; safety; registry:adverse_events |
Vomiting (6 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 160 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 0 / 160 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 29 / 161 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 21 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 161 | not stated; safety; registry:adverse_events |
Diarrhea (3 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 21 / 160 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 24 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 16 / 161 | not stated; safety; registry:adverse_events |
Constipation (6 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 160 | not stated; safety; registry:adverse_events | ||||
| A1 | events | 1 / 160 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 11 / 161 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 2 / 161 | not stated; safety; registry:adverse_events | ||||
| A3 | events | 0 / 161 | 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 | 1 / 160 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A1 | events | 1 / 160 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A2 | events | 0 / 161 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A2 | events | 0 / 161 | not stated; safety; cholecystitis; registry:adverse_events | ||||
| A3 | events | 1 / 161 | not stated; safety; cholecystitis acute; registry:adverse_events | ||||
| A3 | events | 0 / 161 | not stated; safety; cholecystitis; registry:adverse_events |
Pancreatic cancer (3 lines; O38)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 160 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A2 | events | 0 / 161 | not stated; safety; pancreatic carcinoma; registry:adverse_events | ||||
| A3 | events | 1 / 161 | not stated; safety; pancreatic carcinoma; registry:adverse_events |