parallel randomized trial
S003030
Type 2 diabetes (adults)S003030
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide twice daily | oral glucose lowering drugs except sulfonylureas and nateglinide; lifestyle: standard | 33 | 27 | |
| A2 | Premixed insulin Insulin aspart 70/30 | oral glucose lowering drugs except sulfonylureas and nateglinide; lifestyle: standard | 33 | 32 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Exenatide 10 ug subcutaneous twice daily A1 | Premixed insulin A2 |
|---|---|---|---|
| age | mean (years) | 58.85 | 58.03 |
| age | sd (years) | 12.54 | 13.32 |
| bmi | mean (kg/m2) | 23.64 | 24.36 |
| bmi | sd (kg/m2) | 2.86 | 2.52 |
| diabetes duration | mean (years) | 6.59 | 7.81 |
| diabetes duration | sd (years) | 5.32 | 6.02 |
| female | n | 8 | 18 |
| hba1c | mean (percent) | 8.67 | 8.32 |
| hba1c | sd (percent) | 1.03 | 0.96 |
| sbp | mean (mmHg) | 127.03 | 125.46 |
| sbp | sd (mmHg) | 16.48 | 15.04 |
| weight | mean (kg) | 68.68 | 66.30 |
| weight | sd (kg) | 11.95 | 11.42 |
Analyses this trial contributes to
- 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 36 to 64 (target week 52); pairwise 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
- 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
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 36 to 64 (target week 52); network meta-analysis
Results
11 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | -1.31 percent | 1.42 | 27 | not stated; full analysis; R0018574:Table 2 | |
| 52 | A2 | change | -1.09 percent | 1.42 | 32 | not stated; full analysis; R0018574:Table 2 |
Body weight change in kilograms (diabetes) (2 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | -2.21 kg | 3.43 | 27 | not stated; full analysis; R0018574:Table 2 | |
| 52 | A2 | change | 1.57 kg | 2.96 | 32 | not stated; full analysis; R0018574:Table 2 |
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 27 | not stated; full analysis; R0018574:Results | ||||
| A1 | events | 0 / 27 | not stated; full analysis; R0018574:Results | ||||
| A2 | events | 0 / 32 | not stated; full analysis; R0018574:Results | ||||
| A2 | events | 5 / 32 | not stated; full analysis; R0018574:Results |
Systolic blood pressure change (2 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 52 | A1 | change | -1.85 mmHg | 14.35 | 27 | not stated; full analysis; R0018574:Table 2 | |
| 52 | A2 | change | 2.25 mmHg | 18.74 | 32 | not stated; full analysis; R0018574:Table 2 |
Discontinuation due to adverse events (1 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 33 | not stated; randomized; R0018574:Figure 1 |