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Table 3 Schedule of assessments

From: Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision study

Visit 1 2 3 4 5a
Week −4 Baselineb 4 12 24
Screening:      
Informed consent X     
Inclusion/exclusion criteria X X    
Height X     
Thyroid-stimulating hormone X     
Demography/baseline data:      
Demographic information X     
History of diabetes and its complications X     
History/current status X X    
Treatment evaluation:      
Drugs dispensed X X X X  
Drug count/check   X X X X
Dosage records – metformin X X X X X
Dosage records – vildagliptin   X X X X
Currently receiving antihyperglycemic drugs X     
Concomitant medicines X X X X X
Validity assessment:      
HbA1cc X X   X X
Fasting plasma glucose X X X X X
Postprandial glucosed   X    X
Insulind   X    X
Body weight X X X X X
Standard meal test   X    X
Safety evaluation:      
Physical examinations X X    X
Vital signs X X X X X
Electrocardiogram examination X     X
Hematology examinations X X    X
Serum amylase   X X X X
Standard biochemical testse,f X X   X X
Liver function testsf    X   
Pregnancy testg X     X
Routine urine test   X    X
Adverse events X X X X X
Study end      X
  1. aMust also be taken in case of early withdrawal.
  2. bBaseline =1st day of study.
  3. cDetermination of the HbA1c level with no central laboratory requires high-performance liquid chromatography.
  4. dOnly in the standard meal group.
  5. eStandard biochemical examinations include, but are not limited to, the following: fasting blood glucose, liver function, kidney function (serum creatinine and blood urea nitrogen), and lipids (cholesterol and triglycerides).
  6. fLiver function tests include ALT, AST, total and direct bilirubin, and alkaline phosphatase.
  7. gPregnancy tests specifically designed for women of childbearing potential.
  8. HbA1c: glycated hemoglobin.