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Table 3 Study plan detailing the procedures

From: Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial

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   ×        ×
  1. SMBG, self-monitoring of blood glucose; ECG, electrocardiogram; BUN, blood urea nitrogen; CGMS, continuous glucose monitoring system; PPG, postprandial plasma glucose; BW, body weight; BMI, body mass index; WC, waist circumference; MCP-1, monocyte chemotactic protein-1; hs-CPR, high-sensitivity C-reactive protein; 8-Iso-PGF2α, 8-Iso-prostaglandin F2α
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Trials

ISSN: 1745-6215