Table 2.
Study Flow Sheet
| 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 | |||||||||||
Notes on measures
♣ Local lab documentation of HbA1c ≤ 10 must be confirmed within 12 wks prior to conducting the Week-2 screening visit tests
♠ During Week-1 any labs or tests unable to be performed at screening should be completed
* To include pregnancy test (beta-HCG) in women of childbearing potential.
♥ CBC with differential and platelets, urinalysis, liver function (ALT, AST, alkaline phosphatase and total bilirubin), BUN, creatinine, Na, K, Cl, bicarbonate, calcium, phosphorus, and albumin.
♦ Total cholesterol, triglycerides, HDL-cholesterol, and LDL-cholesterol.
1. for body mass index and waist circumference to be measured on subject in the supine position at the level of the umbilicus
2. for BMI Obtained in the morning after a minimum 8 h overnight fast
3. A full 52-week assessment must be performed whenever a subject terminates the study early.