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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