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.