parallel randomized trial
AGAC2
Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo added on CSII | CSII with insulin aspart titrated to glucose targets; lifestyle: not reported | 21 | 21 | |
| A2 | Exenatide 5 ug subcutaneous twice daily GLP-1 analogue (exenatide) added on CSII | CSII with insulin aspart titrated to glucose targets; lifestyle: not reported | 30 | 30 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Exenatide 5 ug subcutaneous twice daily A2 |
|---|---|---|---|
| age | mean (years) | 53.5 | 52.8 |
| age | se (years) | 3.3 | 2.4 |
| bmi | mean (kg/m2) | 27.0 | 28.9 |
| bmi | se (kg/m2) | 1.1 | 0.8 |
| diabetes duration | mean (years) | 12.8 | 11.6 |
| diabetes duration | se (years) | 1.9 | 1.3 |
| female | n | 8 | 14 |
| female | percent | 38 | 47 |
| hba1c | mean (percent) | 10.6 | 10.5 |
| hba1c | se (percent) | 0.3 | 0.2 |
| insulin dose | mean (U/kg) | 0.83 | 0.88 |
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
- 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
- Acute kidney injuryType 2 diabetes (adults); longest follow-up; descriptive only
- Acute kidney injuryType 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
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
- Acute pancreatitisType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
18 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Supplementary Table 2 | ||||
| A1 | events | 9 / 21 | not stated; randomized; R0020827:Supplementary Table 2 | ||||
| A2 | events | 0 / 30 | not stated; randomized; R0020827:Supplementary Table 2 | ||||
| A2 | events | 12 / 30 | not stated; randomized; R0020827:Supplementary Table 2 |
Acute kidney injury (2 lines; O121)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Results | ||||
| A2 | events | 0 / 30 | not stated; randomized; R0020827:Results |
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Supplement Table 2 | ||||
| A2 | events | 0 / 30 | not stated; randomized; R0020827:Supplement Table 2 |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Supplement Table 2 | ||||
| A2 | events | 0 / 30 | not stated; randomized; R0020827:Supplement Table 2 |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Supplement Table 2 | ||||
| A2 | events | 4 / 30 | not stated; randomized; R0020827:Supplement Table 2 |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Supplement Table 2 | ||||
| A2 | events | 4 / 30 | not stated; randomized; R0020827:Supplement Table 2 |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Supplement Table 2 | ||||
| A2 | events | 1 / 30 | not stated; randomized; R0020827:Supplement Table 2 |
Acute pancreatitis (2 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 21 | not stated; randomized; R0020827:Results | ||||
| A2 | events | 0 / 30 | not stated; randomized; R0020827:Results |