Table 1.
Schedule of Events.
| Visit 1 Screening | Visit 2 Randomization |
Visit 3 Month 1 |
Visit 4 Month 3 |
Visit 5 End of Study |
|
|---|---|---|---|---|---|
| Subject Registration to Study | X | ||||
| Inclusion and Exclusion Criteria | X | ||||
| Informed Consent* | X | ||||
| Physical Examination | X | X | X | ||
| Medical History/Update | X | X | X | X | X |
| Record Concomitant Medications | X | X | X | X | X |
| Record Adverse Events | X | X | X | X | |
| Hematology Panel | X | X | X | X | X |
| Chemistry Panel† | X | X | X | X | X |
| Liver Function Tests‡ | X | X | X | X | X |
| Lipid Profile§ | X | X | X | X | X |
| HbA1c levels | X | X | X | X | X |
| Urinalysis Panel | X | X | X | X | X |
| Dispense Study Drug | X | X | X | ||
| Dispense diaries | X | X | X | X | |
| Compensation | X | X | X | X | X |
| Collect empty study drug vials/packages | X | X | X | ||
| Collect completed subject diaries | X | X | X | X |
*
Explained to and signed by subject
†
SMA-18 (or equivalent), creatinine clearance, and insulin levels
‡
Alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, total protein, and albumin
§
Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides