Table 1

Trial outline

Visit	Visit 0 Screening	Visit 1 Randomisation	Telephone contact	Telephone contact	Visit 2 Clinical control	Telephone contact	Visit 3 Clinical control	Telephone contact	Telephone contact	Visit 4 End of treatment	Safety follow-up
Time (weeks)	−4±2	0	1	2	4±2	8±½	12 ± ½	16 ± ½	20 ± ½	26±1	26+2
General
Informed consent	X
Assessment of inclusion and exclusion criteria	X
Demography	X
Medical history	X
Smoking, alcohol	X
Concomitant medication	X	X	X	X	X	X	X	X	X	X
Endpoints
HbA1c	X	X					X			X
Weight, BMI, hip:waist ratio	X	X					X			X
Insulin dose	X	X	X	X	X	X	X	X	X	X
Hypoglycaemic events	X	X	X	X	X	X	X	X	X	X
CGM for 6 days, including registration of carbohydrate counting	X				X					X
7-point PG profile (prior)		X			X		X			X
DXA scan		X								X
ADDQoL		X					X			X
DTSQs		X					X			X
DTSQc										X
Diet recording	X				X					X
Clinical assessment
Physical assessment including height	X
Consultation blood pressure and heart rate	X	X			X		X			X
ECG	X
Arginine test		X								X
Safety
Adverse events	X	X	X	X	X	X	X	X	X	X	X
Blood tests	X	X			X		X			X
Ketones	X	X			X		X			X
Biobank		X			X		X			X
Urinary albumin:creatinine ratio		X					X			X
Urinary HCG	X	(X)			(X)		(X)			(X)
Study medication
Dispensing visits		X			X		X
Drug accountability					X		X			X
Study drug dose titration				X

7-point PG profile, 7-point plasma glucose profile; ADDQoL, The Audit of Diabetes-Dependent Quality of Life; Blood tests, blood haemoglobin, leucocytes and thrombocytes, plasma glucose, potassium, sodium, creatinine, lipids, alanine aminotransferase, aspartate aminotransferase, amylase and lipase, and serum albumin, total serum-ketones, beta-hydroxybutyrate, acetoacetate and cardiovascular disease markers; BMI, body mass index; CGM, continuous glucose monitoring; DTSQs, Diabetes Treatment Satisfactory Questionnaire: status version; DTSQc, Diabetes Treatment Satisfactory Questionnaire: change version; DXA scan, dual-energy X-ray absorptiometry scan; HbA1c, glycated haemoglobin; ketones, measured with FreeStyle Precision β-Ketone© in the finger; urinary albumin:creatinine ratio, 3-day urine collection (morning spot test); urinary HCG, urinary human choriongonadotropin pregnancy test will be performed if menstruation is absent in a woman of childbearing potential.