Table 1.

Study inclusion and exclusion criteria for the IMI DIRECT cohorts.

Cohort 1	Cohort 2
Inclusion criteria	Inclusion criteria
• No treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs	• Patients diagnosed with T2D not <6 months and not >24 months before baseline
• Fasting capillary blood glucose <10 mmol/l at baseline	• Management by lifestyle with or without metformin therapy
• White European	• White European
• Age ≥35 and <75 years	• Age ≥35 and <75
	• Estimated GFR >50 ml/min
	• All HbA1c <60 mmol/mol within previous 3 months
Exclusion criteria	Exclusion criteria
• Diagnosed diabetes of any type, HbA1c ≥48 mmol/mol or fasting plasma glucose ≥7.0 mmol/l or 2 h plasma glucose	• Type 1 diabetes
>11.0 mmol/l previously	• A previous HbA1c >75 mmol/mol
• For women, pregnancy, lactation or plans to conceive within the study period	• Prior treatment with insulin or an oral hypoglycaemic agent other than metformin
• Use of a pacemaker	• BMI <20 or >50 kg/m2
• Any other significant medical reason for exclusion as determined by the investigator	• For women, pregnancy, lactation or plans to conceive within the study period
	• Any other significant medical reason for exclusion as determined by the investigator