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Table 2 Study Flow Sheet

From: A randomized, double-blind, placebo-controlled trial to assess safety and tolerability during treatment of type 2 diabetes with usual diabetes therapy and either Cycloset™ or placebo

   -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
  1. Notes on measures
  2. ♣ Local lab documentation of HbA1c ≤ 10 must be confirmed within 12 wks prior to conducting the Week-2 screening visit tests
  3. ♠ During Week-1 any labs or tests unable to be performed at screening should be completed
  4. * To include pregnancy test (beta-HCG) in women of childbearing potential.
  5. ♥ 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.
  6. ♦ Total cholesterol, triglycerides, HDL-cholesterol, and LDL-cholesterol.
  7. 1. for body mass index and waist circumference to be measured on subject in the supine position at the level of the umbilicus
  8. 2. for BMI Obtained in the morning after a minimum 8 h overnight fast
  9. 3. A full 52-week assessment must be performed whenever a subject terminates the study early.