Table 3.
Hypoglycaemia and serious adverse events during 18 months of intervention
| Metformin+insulin (n=206) | Placebo +insulin (n=206) | p Value | |
|---|---|---|---|
| Severe hypoglycaemia (number of participants with at least one event, N (%)) | 7 (3.4) | 7 (3.4) | 0.9958 |
| Severe hypoglycaemia (number of events (rate among participants with at least one event)) | 15 (2.1) | 12 (1.7) | 0.5654 |
| Non-severe hypoglycaemia (number of participants with at least one event, No (%)) | 157 (76.2) | 156 (75.7) | 0.9374 |
| Non severe hypoglycaemia (number of events (rate among participants with at least one event)) | 4347 (27.7) | 3161 (20.3) | <0.001 |
| Serious adverse events exclusive of severe hypoglycaemia (number of participants with at least one event, N (%)) | 54 (26.2) | 45 (21.8) | 0.3173 |
| Serious adverse events exclusive of severe hypoglycaemia (number of events (rate among participants with at least one event)) | 81 (1.5) | 72 (1.6) | 0.5029 |
Severe hypoglycaemia defined as a hypoglycaemic episode where help from a third person was needed. Non-severe hypoglycaemia defined as an episode with either symptoms of hypoglycaemia and/or measurement of plasmaglucose ≤3.9 mmol/L.