Visit | 1 | 2 | 3 | 4 | 5a |
---|---|---|---|---|---|
Week | −4 | Baselineb | 4 | 12 | 24 |
Screening: | Â | Â | Â | Â | Â |
Informed consent | X | Â | Â | Â | Â |
Inclusion/exclusion criteria | X | X | Â | Â | Â |
Height | X | Â | Â | Â | Â |
Thyroid-stimulating hormone | X | Â | Â | Â | Â |
Demography/baseline data: | Â | Â | Â | Â | Â |
Demographic information | X | Â | Â | Â | Â |
History of diabetes and its complications | X | Â | Â | Â | Â |
History/current status | X | X | Â | Â | Â |
Treatment evaluation: | Â | Â | Â | Â | Â |
Drugs dispensed | X | X | X | X | Â |
Drug count/check | Â | X | X | X | X |
Dosage records – metformin | X | X | X | X | X |
Dosage records – vildagliptin |  | X | X | X | X |
Currently receiving antihyperglycemic drugs | X | Â | Â | Â | Â |
Concomitant medicines | X | X | X | X | X |
Validity assessment: | Â | Â | Â | Â | Â |
HbA1cc | X | X | Â | X | X |
Fasting plasma glucose | X | X | X | X | X |
Postprandial glucosed | Â | X | Â | Â | X |
Insulind | Â | X | Â | Â | X |
Body weight | X | X | X | X | X |
Standard meal test | Â | X | Â | Â | X |
Safety evaluation: | Â | Â | Â | Â | Â |
Physical examinations | X | X | Â | Â | X |
Vital signs | X | X | X | X | X |
Electrocardiogram examination | X | Â | Â | Â | X |
Hematology examinations | X | X | Â | Â | X |
Serum amylase | Â | X | X | X | X |
Standard biochemical testse,f | X | X | Â | X | X |
Liver function testsf | Â | Â | X | Â | Â |
Pregnancy testg | X | Â | Â | Â | X |
Routine urine test | Â | X | Â | Â | X |
Adverse events | X | X | X | X | X |
Study end | Â | Â | Â | Â | X |