Study Period | Screening | Treatment | |||||||
---|---|---|---|---|---|---|---|---|---|
Visit | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 |
Randomization | |||||||||
Week | −1 | 0 (baseline) | 1 | 2 | 4 | 8 | 10 | 12 | 16 |
Day | 0 | ±2 | ±2 | ±7 | ±7 | ±2 | ±7 | ±7 | |
Telephone visit | × | × | × | ||||||
Screening/baseline | |||||||||
Written informed consent | × | ||||||||
Inclusion/exclusion criteria | × | × | |||||||
Demographics | × | ||||||||
Physical examination | × | × | × | × | × | × | |||
Medical/current conditions | × | × | × | × | × | × | × | × | × |
History of diabetes & complications | × | ||||||||
Lifestyle instruction | × | × | × | × | × | × | × | × | × |
Treatment | |||||||||
Drug dispensing and accountability | × | × | × | × | |||||
Concomitant medications | × | × | × | × | × | × | × | × | × |
SMBG | × | × | × | × | × | × | × | ||
Insulin titration | × | × | × | × | × | × | |||
Safety assessments | |||||||||
Pregnancy test (urine) | × | × | |||||||
Physical examination | × | × | × | × | × | × | |||
Vital signs | × | × | × | × | × | × | |||
12-lead ECG | × | × | |||||||
Hematology panel | × | × | |||||||
Urinalysis | × | × | |||||||
Liver function | × | × | |||||||
Creatinine, BUN, uric acid | × | × | |||||||
Lipids | × | × | × | ||||||
Adverse events | × | × | × | × | × | × | × | × | |
Efficacy assessments | |||||||||
HbA1c | × | × | |||||||
Fasting plasma glucose | × | × | × | × | × | × | |||
Fasting insulin and C-peptide | × | × | |||||||
CGMS | × | × | |||||||
Standard meal test:2 h PPG, insulin and C-peptide | × | × | |||||||
BW, BMI and WC | × | × | × | × | × | × | |||
Other assessment | |||||||||
MCP-1, hs-CRP | × | × | |||||||
8-Iso-PGF2α | × | × | |||||||
Urinary albumin | × | × |