Table 2

Trial visits

	Visit 0 Screening	Visit 1 Randomisation	Telephone or email contact	Visit 2 Clinical control	Visit 3 Clinical control	Visit 4 CGM and blood pressure	Visit 5 End of trial
Time (weeks)	−1±1	0	–	3±1	12±1	23±1	24±1
General
Assessment of inclusion and exclusion criteria	X
Demography	X
Medical history	X
Concomitant medication	X	X	X	X	X		X
Smoking/alcohol	X
End points
HbA1c	X	X			X		X
Weight—BMI	X	X		X	X		X
Insulin dose	X	X	X	X	X		X
Hypoglycaemia events		X	X	X	X		X
CGM	X				X	X
DXA scan		X					X
Quality of life, problems in diabetes and treatment satisfaction		X		X			X
Food preference		X		X			X
VAS score for appetite*		X		X			X
Standardised meal test*		X		X			X
Carotid intima media thickness		X					X
Pulse wave velocity		X					X
24 h blood pressure and pulse rate		X				X
Clinical assessment
Physical assessment incl. height	X
Office blood pressure and heart rate	X	X		X	X		X
ECG	X						X
Biosamples
Biomarkers†		X			X		X
U-albumin/creatinine ratio		X					X
Biobank		X					X
Safety
Adverse events		X	X	X	X		X
Blood tests‡	X	X			X		X
Urinary hCG§	X	(X)		(X)	(X)		(X)
Study medication
Drug accountability		X		X	X		X
Study drug dose titration			X				X

*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.