Table 1

Trial design, visits and end points

VisitVisit 0Visit 1Visit 2Visit 3Visit 4Visit*Visit 5
Time (days from the start of intervention)−14−63090180270360
Informed consent×
Inclusion/exclusion criteria×
Body weight×××××××
Waist circumference×××××××
Hip circumference×××××××
Blood pressure×××××××
Glycosylated haemoglobin××××××
Fasting plasma glucose××
Liver function××××××
Renal function××××××
Blood lipid profiles×××××
Urinary albumin/creatinine ratio×××××
Fasting blood samples××
Urine samples××
Visual acuity××××××
Retinal photographs××××××
Retinal vascular calibre×××××
Adverse events×××××
Drug accountability××××××
  • The maximum allowed time interval between screening (visit 0) and baseline examination (visit 1) will be 2 weeks (=14 days). Otherwise, a new screening will be conducted before the participants are included in the study.

  • *Additional visit at 9 months is warranted for patient with type 1 diabetes.