parallel randomized trial
IDEAL
INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | IGlarLixi 2:1 pen subcutaneous once daily titrated iGlarLixi | metformin with or without SGLT2 inhibitor; prandial insulin stopped; lifestyle: standard | 45 | 45 | |
| A2 | Basal bolus insulin Continued MDI insulin regimen | metformin with or without SGLT2 inhibitor; lifestyle: standard | 46 | 45 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | IGlarLixi 2:1 pen subcutaneous once daily titrated A1 | Basal bolus insulin A2 |
|---|---|---|---|
| age | mean (years) | 65.0 | 67.3 |
| age | sd (years) | 9.3 | 7.9 |
| bmi | mean (kg/m2) | 33.7 | 33.5 |
| bmi | sd (kg/m2) | 5.5 | 5.5 |
| diabetes duration | mean (years) | 16.9 | 18.1 |
| diabetes duration | sd (years) | 8.8 | 8.7 |
| established cvd | n | 9 | 15 |
| established cvd | percent | 20 | 33 |
| female | n | 11 | 8 |
| female | percent | 24 | 18 |
| hba1c | mean (percent) | 7.96 | 7.83 |
| hba1c | sd (percent) | 1.01 | 1.00 |
| insulin dose | mean (U/day) | 63 | 59 |
| insulin dose | sd (U/day) | 20 | 22 |
| metformin use | n | 36 | 36 |
| metformin use | percent | 80 | 80 |
| sbp | mean (mmHg) | 144 | 141 |
| sbp | sd (mmHg) | 21 | 16 |
| sglt2i use | n | 20 | 21 |
| sglt2i use | percent | 44 | 47 |
| waist | mean (cm) | 113 | 114 |
| waist | sd (cm) | 11 | 13 |
| weight | mean (kg) | 100 | 102 |
| weight | sd (kg) | 18 | 17 |
| white | n | 45 | 45 |
| white | percent | 100 | 100 |
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
Results
10 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (3 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -0.49 percent | -0.77 to -0.22 | 45 | not stated; full analysis; R0003942:Results | |
| 24 | A1 vs A2 | md | -0.12 percent | -0.48 to 0.23 | not stated; full analysis; R0003942:Results | ||
| 24 | A2 | change | -0.37 percent | -0.61 to -0.14 | 45 | not stated; full analysis; R0003942:Results |
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 24 | A1 | change | -4.78 kg | -6.06 to -3.51 | 45 | not stated; full analysis; R0003942:Results | |
| 24 | A1 vs A2 | md | -4.19 kg | -5.95 to -2.43 | not stated; full analysis; R0003942:Results | ||
| 24 | A2 | change | -0.53 kg | -1.64 to 0.59 | 45 | not stated; full analysis; R0003942:Results |
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / | not stated; other; R0003942:Results | ||||
| A1 | events | 31 | not stated; other; R0003942:Results | ||||
| A2 | events | 0 / | not stated; other; R0003942:Results | ||||
| A2 | events | 40 | not stated; other; R0003942:Results |