Table 1.
Study visit schedule
| Study phase | Metformin run-in (3 months) | Study treatment follow-up (24 months) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Time point | Wk 0 | Wk 2 | Wk 4 | Wk 6 | Wk 8 | Wk 10 | Wk 12/ | Mth 0 | Mth 1 | Mth 3 | Mth 6 | Mth 12 | Mth 18 | Mth 24 |
| Location | Clinic | Phone | Clinic or remote | Phone | Clinic or remote | Phone | Clinic† | Phone | Clinic or remote | Clinic or remote | Clinic | Clinic or remote | Clinic | |
| Screening | ||||||||||||||
| Eligibility | X | X | ||||||||||||
| Informed consent | X | |||||||||||||
| Medical history | X | |||||||||||||
| Clinical assessments | ||||||||||||||
| Concomitant medications | X | X | X | X | X | X | X | X | X | X | X | X | X | |
| Physical examination | X | X | X | X | ||||||||||
| Blood pressure | X | X | X | X | X | X | X | X | X | |||||
| GSRS* | X | X | X | X | ||||||||||
| EQ-5D-5L | X | X | X | X | ||||||||||
| ADPKD-PDS | X | X | X | X | ||||||||||
| Adverse events (as required) | X | X | X | X | X | X | X | X | X | X | X | X | ||
| Local lab assessments | ||||||||||||||
| Full blood count, biochemistry | X | X | X | X | ||||||||||
| Vitamin B12 test | X | |||||||||||||
| Urine assessments | X | X | X | X | ||||||||||
| Urine osmolality test | X | X | X | X | ||||||||||
| Creatinine test‡ | X | X | ||||||||||||
| Pregnancy test≠ | X | X | X | X | ||||||||||
| Central lab assessments∆ | ||||||||||||||
| Cystatin C | X | X | X | X | ||||||||||
| Medication related | ||||||||||||||
| Dispense medication | X | X | X | X | X | |||||||||
| Randomization | X | |||||||||||||
| Return and count unused medication | X | X | X | X | X | |||||||||
†Wk 12 and Mth 0 occur concurrently. *Can be conducted at any time only if Participant reports gastrointestinal symptoms. ‡Creatinine test to determine eGFR during run-in phase to monitor safety. At other time points, eGFR is tested as part of routine local laboratory assessment. ≠Only for female participants of childbearing age. ΔCentral lab assessments for sites with sample processing and storage facility