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.

Scranton et al. BMC Endocrine Disorders 2007 7:3   doi:10.1186/1472-6823-7-3