Table 2.
Trial design and time line of the clinical study.
Screening | Trial Period | |||
---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 |
•Subject Enrollment •Supplementation with placebo •Pre-randomization placebo-run-in period |
•Randomization •Supplementation •Data collection* |
Data collection | Data collection | Data collection |
Placebo-run-in 1 month | 0 (baseline) | 1 month | 2 months | 3 months |
Overnight fasting (12 hours) blood samples, anthropomorphic data, record of daily insulin use and blood glucose levels were collected at each visit.