. 2023 Jul 4;14(9):1503–1515. doi: 10.1007/s13300-023-01435-z

Table 1.

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
HbA1c: > 7%, < 10% (DCCT); 53–86 mmol/mol (IFCC units) Age: > 18 years, < 80 years Duration of diabetes mellitus: minimal 60 months Preserved insulin secretion with C-peptide level at least 10% above the lower limit of the normal range BBIT with duration of at least 12 months Type 2 diabetes mellitus TDDI > 20 IU, < 70 IU/day (approx. > 0.3 < 0.7 IU/kg/day), with stable doses during at least 3 months ± OAD with a stable composition and dose over the last 3 months before screening BMI > 25 kg/m² Ability and willingness to perform SMBG Ability and willingness to wear blinded CGM (3-times for 14 days)—in a selected subgroup of patients	BMI < 25 kg/m², unplanned significant weight lose Any signs of catabolism Type 1 diabetes mellitus including LADA Planned surgery (except for minor short-term procedures) or hospitalization Acute disease < 2 weeks before prescreening with potential effect on glycemic control Chronic disease detected < 3 months before prescreening or unstable with a potential effect on glycemic control or body weight Addition of drugs < 3 months before prescreening with a potential effect on glycemia or body weight Optimal glycemic control on previous insulin treatment Treatment with GLP1-RA Contraindication/intolerance to GLP1-RA, insulin degludec or IDegLira according to the Summary of Product Characteristics eGFR < 15 ml/min/1.73 m² Patients unable to comply with therapeutic regimen Overall unfavorable condition of the patient limiting study participation

Inclusion criteria

Exclusion criteria

HbA1c: > 7%, < 10% (DCCT); 53–86 mmol/mol (IFCC units)

Age: > 18 years, < 80 years

Duration of diabetes mellitus: minimal 60 months

Preserved insulin secretion with C-peptide level at least 10% above the lower limit of the normal range

BBIT with duration of at least 12 months

Type 2 diabetes mellitus

TDDI > 20 IU, < 70 IU/day (approx. > 0.3 < 0.7 IU/kg/day), with stable doses during at least 3 months ± OAD with a stable composition and dose over the last 3 months before screening

BMI > 25 kg/m²

Ability and willingness to perform SMBG

Ability and willingness to wear blinded CGM (3-times for 14 days)—in a selected subgroup of patients

BMI < 25 kg/m², unplanned significant weight lose

Any signs of catabolism

Type 1 diabetes mellitus including LADA

Planned surgery (except for minor short-term procedures) or hospitalization

Acute disease < 2 weeks before prescreening with potential effect on glycemic control

Chronic disease detected < 3 months before prescreening or unstable with a potential effect on glycemic control or body weight

Addition of drugs < 3 months before prescreening with a potential effect on glycemia or body weight

Optimal glycemic control on previous insulin treatment

Treatment with GLP1-RA

Contraindication/intolerance to GLP1-RA, insulin degludec or IDegLira according to the Summary of Product Characteristics

eGFR < 15 ml/min/1.73 m²

Patients unable to comply with therapeutic regimen

Overall unfavorable condition of the patient limiting study participation

BBIT Basal-bolus insulin treatment, BMI body mass index, CGM continuous glucose monitoring, DCCT Diabetes Control and Complications Trial, eGFR estimated glomerular filtration rate, GLP1-RA glucagon-like peptide-1 receptor agonists, HbA1c glycated hemoglobin, IDegLira fixed-combination insulin degludec and liraglutide, IFCC International Federation of Clinical Chemistry, LADA latent autoimmune diabetes of adults, OAD oral antidiabetic drugs, SMBG self-monitoring of blood glucose, TDDI total daily dose of insulin