Assessments and procedures during screening and study visits
| Procedure | D −21 to −2 | D 0 | D 5–6 | D 7 | D 12–13 | D 14 | W 6 | W 10 | W 13–14 | W 14 | W 18 | W 22 | W 25–26 | W 26 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| Informed consent | X | |||||||||||||
| Physical examination | X | X | X | |||||||||||
| Fasting visit | X | X | X | X | X | X | ||||||||
| Bloods | X | X | X | |||||||||||
| Pregnancy test | X | |||||||||||||
| Urinalysis | X | X | ||||||||||||
| Height | X | |||||||||||||
| Weight | X | X | X | X | X | |||||||||
| BP, pulse | X | X | X | X | ||||||||||
| ECG | X | X | ||||||||||||
| Glucometer provision and training | X | |||||||||||||
| Drug dispensing | X | X | X | X | X | |||||||||
| Drug administration | X | X | X | X | X | X | X | X | X | X | ||||
| AE reporting | X | X | X | X | X | X | X | X | X | |||||
| Con-med check | X | X | X | X | X | X | X | X | X | X | ||||
| Compliance check | X | X | X | X | X | X | X | X | X | |||||
| 8 hour urine | X | X | X | X | X | |||||||||
| Telephone reminder | X | X | X | X | X | |||||||||
| Test meal | X | X | X | X | X | |||||||||
| TFEQ | X | X | ||||||||||||
| fMRI | X | X | X | X | X | |||||||||
| MR/MRS | X | X | X |
AE, adverse event; BP, blood pressure; D, day; fMRI, functional MRI; MRS, magnetic resonance spectroscopy; TFEQ, three factor eating quotient; W, week.