Table 2

Trial visits

Visit 0
Screening
Visit 1
Randomisation
Telephone or email contactVisit 2
Clinical control
Visit 3
Clinical control
Visit 4 CGM and
blood pressure
Visit 5
End of trial
Time (weeks)−1±103±112±123±124±1
General     
 Assessment of inclusion and exclusion criteriaX
 DemographyX
 Medical historyX
 Concomitant medicationXXXXXX
 Smoking/alcoholX
End points
 HbA1cXXXX
 Weight—BMIXXXXX
 Insulin doseXXXXXX
 Hypoglycaemia eventsXXXXX
 CGMXXX
 DXA scanXX
 Quality of life, problems in diabetes and treatment satisfactionXXX
 Food preferenceXXX
 VAS score for appetite*XXX
 Standardised meal test*XXX
 Carotid intima media thicknessXX
 Pulse wave velocityXX
 24 h blood pressure and pulse rateXX
Clinical assessment
 Physical assessment incl. heightX
 Office blood pressure and heart rateXXXXX
 ECGXX
Biosamples
 Biomarkers†XXX
 U-albumin/creatinine ratioXX
 BiobankXX
Safety
 Adverse eventsXXXXX
 Blood tests‡XXXX
 Urinary hCG§X(X)(X)(X)(X)
Study medication
 Drug accountabilityXXXX
 Study drug dose titrationXX
  • *The first 40 patients.

  • †Biomarkers: Leptin, GLP-2, Adiponectin, GAD antibodies, C-peptide, NT-proBNP, hsCRP.

  • ‡Glucose, haemoglobin, leucocytes, thrombocytes, potassium, sodium, creatinine, albumin, lipids, alanine transferase, lipase, amylase.

  • §Urinary hCG will be performed if menstruation is absent in a woman of childbearing potential.

  • BMI, body mass index; CGM, continuous glucose monitoring; DXA, dual-energy X-ray absorptiometry; GAD, glutamic acid decarboxylase; GLP, glucagon-like peptide; hCG, human chorionic gonadotropin; hsCRP, high-sensitive C reactive protein; NT-proBNP, N-terminal prohormone brain natriuretic peptide; VAS, visual analogue scale.