1.1 All‐cause mortality |
9 |
3334 |
Peto Odds Ratio (Peto, Fixed, 95% CI) |
4.97 [0.79, 31.38] |
1.1.1 Adults |
6 |
2558 |
Peto Odds Ratio (Peto, Fixed, 95% CI) |
4.97 [0.79, 31.38] |
1.1.2 Children |
3 |
776 |
Peto Odds Ratio (Peto, Fixed, 95% CI) |
Not estimable |
1.2 All‐cause mortality (published vs. unpublished data) |
9 |
3334 |
Risk Ratio (M‐H, Random, 95% CI) |
3.64 [0.42, 31.40] |
1.2.1 Published |
2 |
842 |
Risk Ratio (M‐H, Random, 95% CI) |
4.47 [0.24, 82.58] |
1.2.2 Unpublished |
7 |
2492 |
Risk Ratio (M‐H, Random, 95% CI) |
2.85 [0.12, 69.55] |
1.3 Severe hypoglycaemia |
8 |
3219 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.52, 0.92] |
1.3.1 Adults |
5 |
2443 |
Risk Ratio (M‐H, Random, 95% CI) |
0.71 [0.49, 1.03] |
1.3.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.61 [0.30, 1.23] |
1.4 Severe hypoglycaemia (published vs. unpublished data) |
8 |
3175 |
Risk Ratio (M‐H, Random, 95% CI) |
0.69 [0.51, 0.93] |
1.4.1 Published |
6 |
2677 |
Risk Ratio (M‐H, Random, 95% CI) |
0.62 [0.50, 0.78] |
1.4.2 Unpublished |
2 |
498 |
Risk Ratio (M‐H, Random, 95% CI) |
1.42 [0.77, 2.62] |
1.5 Hypoglycaemia reported as a serious adverse event |
8 |
3219 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.51, 1.71] |
1.5.1 Adults |
5 |
2443 |
Risk Ratio (M‐H, Random, 95% CI) |
0.94 [0.48, 1.86] |
1.5.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.16, 5.57] |
1.6 Cardiovascular mortality |
9 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
1.6.1 Adults |
6 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
1.6.2 Children |
3 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Totals not selected |
1.7 Non‐fatal myocardial infarction |
1 |
|
Risk Ratio (M‐H, Fixed, 95% CI) |
Subtotals only |
1.8 Serious adverse events |
9 |
3332 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.75, 1.21] |
1.8.1 Adults |
6 |
2556 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.73, 1.28] |
1.8.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.89 [0.56, 1.43] |
1.9 Serious adverse events (published vs. unpublished data) |
9 |
3332 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.75, 1.21] |
1.9.1 Published |
2 |
641 |
Risk Ratio (M‐H, Random, 95% CI) |
0.66 [0.40, 1.09] |
1.9.2 Unpublished |
7 |
2691 |
Risk Ratio (M‐H, Random, 95% CI) |
1.06 [0.80, 1.39] |
1.10 Diabetic ketoacidosis |
6 |
2012 |
Risk Ratio (M‐H, Random, 95% CI) |
0.80 [0.36, 1.76] |
1.10.1 Adults |
3 |
1236 |
Risk Ratio (M‐H, Random, 95% CI) |
0.84 [0.24, 2.92] |
1.10.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.77 [0.27, 2.15] |
1.11 Diabetic ketoacidosis (published vs. unpublished data) |
6 |
2012 |
Risk Ratio (M‐H, Random, 95% CI) |
0.80 [0.36, 1.76] |
1.11.1 Published data |
2 |
694 |
Risk Ratio (M‐H, Random, 95% CI) |
0.83 [0.27, 2.52] |
1.11.2 Unpublished data |
4 |
1318 |
Risk Ratio (M‐H, Random, 95% CI) |
0.77 [0.25, 2.38] |
1.12 Non‐serious adverse events |
9 |
3332 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.95, 1.01] |
1.12.1 Adults |
6 |
2556 |
Risk Ratio (M‐H, Random, 95% CI) |
0.99 [0.95, 1.03] |
1.12.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.96 [0.90, 1.02] |
1.13 Non‐serious adverse events (published vs unpublished data) |
9 |
3332 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.94, 1.01] |
1.13.1 Published data |
3 |
1141 |
Risk Ratio (M‐H, Random, 95% CI) |
0.95 [0.90, 1.01] |
1.13.2 Unpublished data |
6 |
2191 |
Risk Ratio (M‐H, Random, 95% CI) |
1.00 [0.95, 1.04] |
1.14 Withdrawals due to adverse events |
8 |
3222 |
Risk Ratio (M‐H, Random, 95% CI) |
2.23 [0.98, 5.05] |
1.14.1 Adults |
5 |
2445 |
Risk Ratio (M‐H, Random, 95% CI) |
2.25 [0.94, 5.41] |
1.14.2 Children |
3 |
777 |
Risk Ratio (M‐H, Random, 95% CI) |
2.08 [0.22, 19.90] |
1.15 Any nocturnal hypoglycaemia |
8 |
3219 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.87, 0.95] |
1.15.1 Adults |
5 |
2443 |
Risk Ratio (M‐H, Random, 95% CI) |
0.93 [0.88, 0.98] |
1.15.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.87 [0.81, 0.94] |
1.16 Mild nocturnal hypoglycaemia |
7 |
3073 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.85, 0.96] |
1.16.1 Adults |
4 |
2149 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.83, 1.00] |
1.16.2 Children |
3 |
924 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.78, 1.00] |
1.17 Nocturnal hypoglycaemia (symptoms) |
6 |
2578 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.79, 0.98] |
1.17.1 Adults |
4 |
2149 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.82, 1.01] |
1.17.2 Children |
2 |
429 |
Risk Ratio (M‐H, Random, 95% CI) |
0.55 [0.19, 1.61] |
1.18 Severe nocturnal hypoglycaemia |
7 |
2925 |
Risk Ratio (M‐H, Random, 95% CI) |
0.67 [0.39, 1.17] |
1.18.1 Adults |
4 |
2149 |
Risk Ratio (M‐H, Random, 95% CI) |
0.57 [0.35, 0.93] |
1.18.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.64 [0.13, 3.17] |
1.19 Any nocturnal hypoglycaemia (published vs. unpublished data) |
8 |
3219 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.87, 0.95] |
1.19.1 Published |
6 |
2677 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.86, 0.95] |
1.19.2 Unpublished |
2 |
542 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.80, 1.04] |
1.20 Mild nocturnal hypoglycaemia (published vs. unpublished data) |
7 |
3073 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.85, 0.96] |
1.20.1 Published |
4 |
2084 |
Risk Ratio (M‐H, Random, 95% CI) |
0.91 [0.85, 0.98] |
1.20.2 Unpublished |
3 |
989 |
Risk Ratio (M‐H, Random, 95% CI) |
0.89 [0.75, 1.07] |
1.21 Nocturnal hypoglycaemia, symptoms only (published vs. unpublished data) |
6 |
2578 |
Risk Ratio (M‐H, Random, 95% CI) |
0.88 [0.79, 0.98] |
1.21.1 Published |
3 |
1589 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.81, 0.99] |
1.21.2 Unpublished |
3 |
989 |
Risk Ratio (M‐H, Random, 95% CI) |
0.79 [0.57, 1.08] |
1.22 Severe nocturnal hypoglycaemia (published vs. unpublished data) |
7 |
2925 |
Risk Ratio (M‐H, Random, 95% CI) |
0.67 [0.39, 1.17] |
1.22.1 Published |
5 |
2383 |
Risk Ratio (M‐H, Random, 95% CI) |
0.63 [0.32, 1.25] |
1.22.2 Unpublished |
2 |
542 |
Risk Ratio (M‐H, Random, 95% CI) |
0.90 [0.33, 2.45] |
1.23 Nocturnal hypoglycaemia, asymptomatic (children vs. adults) |
2 |
429 |
Risk Ratio (M‐H, Random, 95% CI) |
0.96 [0.78, 1.18] |
1.24 Mild/moderate hypoglycaemia |
8 |
3219 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.94, 0.99] |
1.24.1 Adults |
5 |
2443 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.93, 1.02] |
1.24.2 Children |
3 |
776 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.93, 1.01] |
1.25 Mild/moderate hypoglycaemia (published vs. unpublished data) |
8 |
3219 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.94, 0.99] |
1.25.1 Published |
6 |
2677 |
Risk Ratio (M‐H, Random, 95% CI) |
0.97 [0.93, 1.00] |
1.25.2 Unpublished |
2 |
542 |
Risk Ratio (M‐H, Random, 95% CI) |
0.98 [0.92, 1.05] |
1.26 HbA1c |
8 |
3122 |
Mean Difference (IV, Random, 95% CI) |
0.01 [‐0.08, 0.10] |
1.26.1 Adults |
5 |
2354 |
Mean Difference (IV, Random, 95% CI) |
‐0.03 [‐0.14, 0.07] |
1.26.2 Children |
3 |
768 |
Mean Difference (IV, Random, 95% CI) |
0.13 [‐0.04, 0.31] |
1.27 HbA1c (published vs. unpublished data) |
8 |
3122 |
Mean Difference (IV, Random, 95% CI) |
0.00 [‐0.09, 0.09] |
1.27.1 Published |
6 |
2624 |
Mean Difference (IV, Random, 95% CI) |
‐0.02 [‐0.13, 0.09] |
1.27.2 Unpublished |
2 |
498 |
Mean Difference (IV, Random, 95% CI) |
0.10 [‐0.08, 0.28] |