| Required Investigations | Prestudy | Telephone calls | 6 weeks after start treatment | 3 months after start treatment (end of treatment) |
|---|
| Written informed consent | X | | | |
| Demographics | X | | | |
| Overall medical history | X | | | |
| ECOG/WHO performance status | X | X | X | X |
| Adverse events | | X | X | X |
| EORTC QLQ-NMIBC24 | X | | X | X |
| SF-36 quality of life | X | | X | X |
| Medication diary | | X | X | X |
| Physical: | | | | |
| Physical examination | X | | X | X |
| TURB | X | | | X |
| Haematology: | | | | |
| Complete blood counts | X | | X | X |
| PT, APTT | X | | | |
| Clinical chemistry: | | | | |
| Renal function | X | | X | X |
| Liver function | X | | X | X |
| Serum glucose | X | | X | X |
| HbA1c | X | | | X |
| Insulin | X | | | X |
| IGF-1 | X | | | X |
| IGF binding protein-3 | X | | | X |
| Other Investigations: | | | | |
| Metformin concentration in serum | | | X | X |
| Metformin concentration in urine | | | X | X |
| Urinalysis | X | | X | X |
| Pathological review of biopsies | X | | | X |
- Abbreviations: ECOG Eastern Cooperative Oncology Group, IGF insulin growth factor, WHO World Health Organisation
