2.1 All‐cause mortality |
8 |
2175 |
Peto Odds Ratio (Peto, Fixed, 95% CI) |
0.14 [0.00, 6.98] |
2.1.1 Adults |
4 |
1365 |
Peto Odds Ratio (Peto, Fixed, 95% CI) |
0.14 [0.00, 6.98] |
2.1.2 Children |
4 |
810 |
Peto Odds Ratio (Peto, Fixed, 95% CI) |
Not estimable |
2.2 Health‐realted quality of life |
2 |
880 |
Mean Difference (IV, Random, 95% CI) |
0.62 [‐0.71, 1.96] |
2.3 Severe hypoglycaemia |
9 |
2350 |
Risk Ratio (M‐H, Random, 95% CI) |
0.84 [0.67, 1.04] |
2.3.1 Adults |
5 |
1540 |
Risk Ratio (M‐H, Random, 95% CI) |
0.78 [0.58, 1.05] |
2.3.2 Children |
4 |
810 |
Risk Ratio (M‐H, Random, 95% CI) |
1.14 [0.59, 2.21] |
2.4 Severe hypoglycaemia (published vs. unpublished data) |
9 |
2350 |
Risk Ratio (M‐H, Random, 95% CI) |
0.84 [0.67, 1.04] |
2.4.1 Published |
7 |
1691 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.63, 1.22] |
2.4.2 Unpublished |
2 |
659 |
Risk Ratio (M‐H, Random, 95% CI) |
0.83 [0.56, 1.25] |
2.5 Hypoglycaemia reported as a serious adverse event |
8 |
2229 |
Risk Ratio (M‐H, Random, 95% CI) |
0.94 [0.64, 1.39] |
2.5.1 Adults |
4 |
1419 |
Risk Ratio (M‐H, Random, 95% CI) |
0.89 [0.57, 1.37] |
2.5.2 Children |
4 |
810 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.32, 2.87] |
2.6 Cardiovascular mortality |
8 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
2.6.1 Adults |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
2.6.2 Children |
4 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
2.7 Non‐fatal myocardial infarction |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.8 Non‐fatal stroke |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.9 Serious adverse events |
8 |
2229 |
Risk Ratio (M‐H, Random, 95% CI) |
1.08 [0.63, 1.84] |
2.9.1 Adults |
4 |
1419 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.72, 1.35] |
2.9.2 Children |
4 |
810 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.28, 3.64] |
2.10 Serious adverse events (published vs. unpublished data) |
8 |
2229 |
Risk Ratio (M‐H, Random, 95% CI) |
1.08 [0.63, 1.84] |
2.10.1 Published |
4 |
1284 |
Risk Ratio (M‐H, Random, 95% CI) |
1.11 [0.45, 2.70] |
2.10.2 Unpublished |
4 |
945 |
Risk Ratio (M‐H, Random, 95% CI) |
1.10 [0.46, 2.60] |
2.11 Diabetic ketoacidosis |
7 |
2054 |
Risk Ratio (M‐H, Random, 95% CI) |
0.53 [0.19, 1.44] |
2.11.1 Adults |
3 |
1244 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.11, 9.58] |
2.11.2 Children |
4 |
810 |
Risk Ratio (M‐H, Random, 95% CI) |
0.45 [0.15, 1.39] |
2.12 Diabetic ketoacidosis (published vs. unpublished data) |
7 |
2054 |
Risk Ratio (M‐H, Random, 95% CI) |
0.53 [0.19, 1.44] |
2.12.1 Published |
3 |
685 |
Risk Ratio (M‐H, Random, 95% CI) |
0.39 [0.11, 1.31] |
2.12.2 Unpublished |
4 |
1369 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.18, 5.77] |
2.13 Non‐serious adverse events |
8 |
2229 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.96, 1.06] |
2.13.1 Adults |
4 |
1419 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.95, 1.07] |
2.13.2 Children |
4 |
810 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.93, 1.12] |
2.14 Non‐serious adverse events (published vs. unpublished data) |
8 |
2229 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.96, 1.06] |
2.14.1 Published |
5 |
1308 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.94, 1.05] |
2.14.2 Unpublished |
3 |
921 |
Risk Ratio (M‐H, Random, 95% CI) |
1.03 [0.94, 1.14] |
2.15 Withdrawals due to adverse events |
8 |
2230 |
Risk Ratio (M‐H, Random, 95% CI) |
0.83 [0.24, 2.81] |
2.15.1 Adults |
4 |
1419 |
Risk Ratio (M‐H, Random, 95% CI) |
1.74 [0.29, 10.39] |
2.15.2 Children |
4 |
811 |
Risk Ratio (M‐H, Random, 95% CI) |
0.30 [0.06, 1.53] |
2.16 Nocturnal hypoglycaemia |
7 |
2054 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.96, 1.05] |
2.16.1 Adults |
3 |
1244 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.92, 1.06] |
2.16.2 Children |
4 |
810 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.95, 1.08] |
2.17 Mild nocturnal hypoglycaemia |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
2.18 Nocturnal hypoglycaemia (symptoms) |
4 |
996 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.82, 1.05] |
2.18.1 Adults |
2 |
710 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.88, 1.08] |
2.18.2 Children |
2 |
286 |
Risk Ratio (M‐H, Random, 95% CI) |
0.74 [0.55, 1.00] |
2.19 Severe nocturnal hypoglycaemia |
6 |
1893 |
Risk Ratio (M‐H, Random, 95% CI) |
0.83 [0.62, 1.12] |
2.19.1 Adults |
3 |
1244 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.60, 1.27] |
2.19.2 Children |
3 |
649 |
Risk Ratio (M‐H, Random, 95% CI) |
0.77 [0.47, 1.25] |
2.20 Nocturnal hypoglycaemia (published vs. unpublished data) |
7 |
2054 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.96, 1.05] |
2.20.1 Published |
5 |
1345 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.95, 1.06] |
2.20.2 Unpublished |
2 |
709 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.91, 1.08] |
2.21 Symptomatic nocturnal hypoglycaemia (published vs. unpublished data) |
4 |
996 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.82, 1.05] |
2.21.1 Published |
3 |
871 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.67, 1.12] |
2.21.2 Unpublished |
1 |
125 |
Risk Ratio (M‐H, Random, 95% CI) |
0.94 [0.80, 1.10] |
2.22 Mild/moderate hypoglycaemia |
7 |
2054 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [1.00, 1.04] |
2.22.1 Adults |
3 |
1244 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [0.99, 1.06] |
2.22.2 Children |
4 |
810 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.99, 1.04] |
2.23 Mild/moderate hypoglycaemia (published vs. unpublished data) |
7 |
2054 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [1.00, 1.04] |
2.23.1 Published |
5 |
1395 |
Risk Ratio (M‐H, Random, 95% CI) |
1.02 [1.00, 1.05] |
2.23.2 Unpublished |
2 |
659 |
Risk Ratio (M‐H, Random, 95% CI) |
1.01 [0.98, 1.05] |
2.24 HbA1c |
9 |
2285 |
Mean Difference (IV, Random, 95% CI) |
0.02 [‐0.06, 0.11] |
2.24.1 Adults |
5 |
1523 |
Mean Difference (IV, Random, 95% CI) |
‐0.01 [‐0.16, 0.13] |
2.24.2 Children |
4 |
762 |
Mean Difference (IV, Random, 95% CI) |
0.03 [‐0.13, 0.20] |
2.25 HbA1c (published vs unpublished data) |
9 |
2285 |
Mean Difference (IV, Random, 95% CI) |
0.02 [‐0.06, 0.11] |
2.25.1 Published |
6 |
1868 |
Mean Difference (IV, Random, 95% CI) |
0.02 [‐0.09, 0.14] |
2.25.2 Unpublished |
3 |
417 |
Mean Difference (IV, Random, 95% CI) |
‐0.04 [‐0.26, 0.18] |
2.26 HbA1c (NPH < 2x/day vs ≥ 2x/day) |
9 |
2285 |
Mean Difference (IV, Random, 95% CI) |
0.02 [‐0.06, 0.11] |
2.26.1 NPH up to twice a day |
8 |
2164 |
Mean Difference (IV, Random, 95% CI) |
0.05 [‐0.03, 0.13] |
2.26.2 NPH more than twice a day |
1 |
121 |
Mean Difference (IV, Random, 95% CI) |
‐0.50 [‐0.93, ‐0.07] |