Table 4.

Summary of efficacy and hypoglycaemia data for insulin degludec versus insulin glargine in clinical trials in adult subjects with type 1 or type 2 diabetes mellitus

Study name	Study population	Efficacy		Changes in the rate of hypoglycaemia with IDeg vs. IGlar (% reduction)
		Reduction in HbA1c with IDeg vs. IGlar, ETD (%)	Reduction in FPG levels with IDeg vs. IGlar, ETD (mmol/L)	Overall confirmed hypoglycaemia	Nocturnal confirmed hypoglycaemia
BEGIN®: T1 [48]	T1DM	−0.01; non-inferior	−0.33	7 ↑	25 ↓
BEGIN®: Flex T1 [49]a	T1DM	0.17; non-inferior	−0.05	3 ↑	40 ↓
BEGIN®: Once Long [50]	T2DM, insulin naive	0.09; non-inferior	−0.43	18 ↓	36 ↓
BEGIN®: LOW VOLUME [51]	T2DM, insulin naive	0.04; non-inferior	−0.42	14 ↓	36 ↓
BEGIN®: BB [52]	T2DM	0.08; non-inferior	−0.29	18 ↓	25 ↓
BEGIN®: FLEX [53]b	T2DM, insulin naive and insulin treated	0.04; non-inferior	−0.42	3 ↑	23 ↓
BEGIN®: ONCE ASIA [54]	T2DM, insulin naive	0.11; non-inferior	−0.09	18 ↓	38 ↓

The values in bold indicate a significant difference between insulin degludec and insulin glargine (p < 0.05)

ETD estimated treatment difference, FPG fasting plasma glucose, HbA _1c glycated haemoglobin, IDeg insulin degludec, IGlar insulin glargine, T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus

^aIDeg ‘Forced-flex’ (IDeg administered in a fixed schedule with 8–40 h interval between doses) data compared with IGlar

^bIDeg ‘Flex’ (IDeg administered in a pre-specified dosing schedule with 8–40 h interval between doses) data compared with IGlar