Table 1.
Schedule for study procedures
| Visit time | Week | Observation period | Treatment period | Discontinuation | ||
|---|---|---|---|---|---|---|
| −4 | 0 | 4 | 12 | |||
| Time window (days) | −29 to −1 | 0 | 21–35 | 70–97 | Until 14 days after last dose | |
| Visit number | 1 | 2 | 3 | 4 | ||
| Informed consent procedure | X | |||||
| Inclusion/exclusion criteria | X | X | ||||
| Demographic data, previous history | X | |||||
| Medical examination | X | X | X | X | X | |
| Height | X | |||||
| Weight | X | X | X | X | X | |
| BMI | X | |||||
| Vital signs | X | X | X | X | X | |
| Concomitant medications | X | X | X | X | X | |
| Concurrent medical conditions | X | X | ||||
| Laboratory tests | ||||||
| Blood chemistry | X | X | X | X | X | |
| Urinalysis | X | X | X | X | X | |
| Drug dispensation (study drug/comparator drug) | X | X | ||||
| Treatment adherence | X | X | X | X | ||
| Basic Information on Study Subject (Your Basic Profile) | X | X | X | X | X | |
| DTSQ | X | X | X | X | ||
| DTR-QOL | X | X | X | X | X | |
| Adverse events evaluation | X → | ← X → | ← X | ← X | ||
| Incidence of hypoglycemia | X → | ← X → | ← X | ← X | ||
| Hospitalization for type 2 diabetes | X → | ← X → | ← X | ← X | ||
BMI body mass index, DTSQ Diabetes Treatment Satisfaction questionnaire, DTR-QOL Diabetes Therapy-Related Quality of Life questionnaire