STUDY WEEK | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
-2 | -1 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 12 | 24 | 36 | 52 | Termination3 | ||
Assessment and Measurement | Pre-Screen | Screen | ♠ | ||||||||||||
HbA1c: Local lab < 10 | ♣ | ♣ | |||||||||||||
Clinic Visit | X | X | X | X | X | X | X | X | X | ||||||
Medical History | X | ||||||||||||||
Concomitant Meds and Illnesses | X | X | X | X | X | X | X | X | |||||||
Pregnancy test* | X | ||||||||||||||
Full Physical Exam, (Weight & Waist Circumference) 1 | X | X | X | X | |||||||||||
Blood pressure | XX | X | X | X | X | XX | X | X | X | ||||||
Record Adverse events (AE) | X | X | X | X | X | X | X | X | |||||||
ECG | X | X | X | X | |||||||||||
Telephone Call to Subject for AE's Reports | X | X | X | X | |||||||||||
CBC & Plasma Sample | X | X | X | X | |||||||||||
Chemistry, LAE♥ | X⊕ | X | X | X | X | ||||||||||
HbA1c | X | X | X | X | X | X | |||||||||
Fasting Plasma Glucose2 | X | X | X | X | X | X | X | X | X | ||||||
Fasting Lipid Profile♦2 | X | X | X | X |