| Characteristic | Hamilton 2003 | Sarnblad 2003 |
| Intervention 1 (I1) / control 1 (C1) | I1: oral metformin and s.c. insulin (randomised[n]=15) C1: placebo and s.c. insulin (randomised[n]=15) | I1: oral metformin and s.c. insulin (randomised[n]=16) C1: placebo and s.c. insulin (randomised[n]=14) |
| [n] of participants who died | N | Not reported |
| [n] adverse events (I1/ I2 / C1 / total) | I:11 C: 7 Total: 18 | I: 3 C: 6 Total: 9 |
| [%] adverse events | I: 73% C: 47% | I: 19% C: 43% |
| [n] serious adverse events | I: 2 C: 2 | N |
| [%] serious adverse events | I: 13% C: 13% | N |
| [n] drop‐outs due to adverse events | I1: 2 C1: 1 Total:3 | I: 1 C: 0 |
| [%] drop‐outs due to adverse events | I1: 13% C1: 7% Total:20% | I: 6% C: 0% |
| [n] hypoglycaemic episodes | I:2 C:1 mild hypoglycemia after 3 months: I: Mean 1.75 (0.8) events/patient/week C: Mean 0.9 (0.4) events/patient/week | N |
| [%] hypoglycaemic episodes | I: 13% C: 7% | N |
| [n] severe hypoglycaemic episodes | I: 2 C:1 | N |
| [%] severe hypoglycaemic episodes | I: 13% C: 7% | N |
| [n] nocturnal hypoglycaemic episodes | ? | N |
| [%] nocturnal hypoglycaemic episodes | ? | N |
| [n] with symptoms | I: 2 C: 1 | N |
| [%] with symptoms | I: 13% C: 7% | N |
| [n] with GIT upset | I: 9 C: 5 | I: 3 C: 6 Total: 9 |
| [%] with GIT upset | I: 60% C: 33% | I: 19% C: 43% |
| [%] with severe GIT upset | I:13% C:0% | N |
| [n] with lactic acidosis | N | N |
| [%] with lactic acidosis | N | N |
| [%] with severe lactic acidosis | N | N |
| Footnotes: Y = yes; N = no; ? = unclear I = intervention; C = control | ||