Study ID	Endpoints	Definition
Ensor 2015	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	Body weight
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	BMI
	Lipid profile	Blood lipids (total cholesterol, HDL and LDL cholesterol, triglyceride levels; IO)
	Glucose levels (fasting and postprandial)	Fasting blood glucose (IO)
	Insulin sensitivity/serum insulin	Insulin (IO)
	All hypoglycaemic events	Reported episodes of hypoglycaemia (SO)
	Severe/serious hypoglycaemia	‐
	Nocturnal hypoglycaemia	‐
	Severe/serious adverse events (specify)	Incidence of SAEs
Barriocanal 2008	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	Weight (IO)
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	Waist circumference, BMI (IO)
	Lipid profile	Total cholesterol, HDL and LDL cholesterol, triglycerides (IO)
	Glucose levels (fasting and postprandial)	Glucose (IO)
	Insulin sensitivity/serum insulin	Insulin (IO)
	All hypoglycaemic events	ND
	Severe/serious hypoglycaemia	ND
	Nocturnal hypoglycaemia	ND
	Severe/serious adverse events (specify)	ND
Maki 2008	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	Body weight (IO)
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	‐
	Lipid profile	Fasting lipids (total cholesterol, LDL cholesterol, HDL cholesterol, non‐HDL cholesterol, triglycerides) (IO)
	Glucose levels (fasting and postprandial)	Fasting glucose (IO)
	Insulin sensitivity/serum insulin	Fasting insulin (IO)
	All hypoglycaemic events	Frequency of hypoglycaemic episodes
	Severe/serious hypoglycaemia	Severe hypoglycaemic episode: "required assistance from another person to actively administer carbohydrate, glucagon, or other resuscitative actions"
	Nocturnal hypoglycaemia	ND
	Severe/serious adverse events (specify)	ND
Grotz 2003	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	‐
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	‐
	Lipid profile	‐
	Glucose levels (fasting and postprandial)	Fasting plasma glucose (IO)
	Insulin sensitivity/serum insulin	‐
	All hypoglycaemic events	ND
	Severe/serious hypoglycaemia	ND
	Nocturnal hypoglycaemia	ND
	Severe/serious adverse events (specify)	ND
Colagiuri 1989	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	Body weight (IO)
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	‐
	Lipid profile	Serum lipids (total and HDL cholesterol and triglycerides) (IO)
	Glucose levels (fasting and postprandial)	Fasting concentrations of plasma glucose (IO)
	Insulin sensitivity/serum insulin	Serum insulin (IO)
	All hypoglycaemic events	‐
	Severe/serious hypoglycaemia	‐
	Nocturnal hypoglycaemia	‐
	Severe/serious adverse events (specify)	‐
Cooper 1988	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	Weight (IO)
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	‐
	Lipid profile	Fasting triglycerides, fasting total cholesterol, fasting LDL cholesterol, fasting HDL cholesterol (IO)
	Glucose levels (fasting and postprandial)	Fasting blood glucose (IO)
	Insulin sensitivity/serum insulin	Fasting plasma insulin (IO)
	All hypoglycaemic events	‐
	Severe/serious hypoglycaemia	‐
	Nocturnal hypoglycaemia	‐
	Severe/serious adverse events (specify)	‐
Chantelau 1985	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	Body weight (IO)
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	‐
	Lipid profile	Total cholesterol, HDL cholesterol, triglycerides (IO)
	Glucose levels (fasting and postprandial)	Daily blood glucose readings ("self‐monitoring using battery powered reflectance meters or reagent strips only") (SO), random postprandial plasma glucose (IO)
	Insulin sensitivity/serum insulin	‐
	All hypoglycaemic events	‐
	Severe/serious hypoglycaemia	‐
	Nocturnal hypoglycaemia	‐
	Severe/serious adverse events (specify)	‐
Nehrling 1985	All‐cause mortality	‐
	Diabetes‐related complications	‐
	HbA1c	HbA1c (IO)
	Health‐related quality of life	‐
	Body weight (kg)	‐
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	‐
	Lipid profile	‐
	Glucose levels (fasting and postprandial)	Fasting plasma glucose, 2‐hour postprandial plasma glucose (IO)
	Insulin sensitivity/serum insulin	‐
	All hypoglycaemic events	ND
	Severe/serious hypoglycaemia	ND
	Nocturnal hypoglycaemia	ND
	Severe/serious adverse events (specify)	ND
Stern 1976	‐	‐
	Diabetes‐related complications	‐
	HbA1c	‐
	Health‐related quality of life	‐
	Body weight (kg)	Weight (IO)
	Socioeconomic effects	‐
	Anthropometric measures other than body weight (kg)	‐
	Lipid profile	Cholesterol, triglycerides (IO)
	Glucose levels (fasting and postprandial)	Fasting glucose (IO)
	Insulin sensitivity/serum insulin	‐
	All hypoglycaemic events	ND
	Severe/serious hypoglycaemia	ND
	Nocturnal hypoglycaemia	ND
	Severe/serious adverse events (specify)	ND
‐: denotes not reported aIn addition to definition of endpoint measurement, description of who measured the outcome (AO: adjudicated outcome measurement; IO: investigator‐assessed outcome measurement; SO: self‐reported outcome measurement). BMI: body mass index; HbA1c: glycosylated haemoglobin A1c; HDL: high‐density lipoprotein; LDL: low‐density lipoprotein; ND: not defined; SAEs: serious adverse events.