Table 2.
Studies evaluating the efficacy of IDegLira and IGlarLixi in patients with diabetes mellitus type 2 inadequately controlled with basal insulin
| Study | DUAL-2 | DUAL-5 | LixiLan L | |||
|---|---|---|---|---|---|---|
| IDegLira | Degludec | IDegLira | Glargine U100 | IGlarLixi | Glargine U100 | |
| Duration | 26 weeks | 26 weeks | 30 weeks | |||
| Population | 413 T2DM adults, A1c 8.7 ± 0.7%, basal insulin and metformin ± sulphonylureas or glinides; mean basal insulin dose at baseline 29 ± 8 | 557 T2DM, A1c 8.4/8.2 ± 0.9%, basal insulin (glargine) and metformin; mean basal insulin dose at baseline 31 ± 10 | 736 T2DM adults, A1c 8.1 ± 0.7%, basal insulin and metformin ± OAD; mean basal insulin dose at baseline 35 ± 9 | |||
| Mean insulin dose (final) | 45 | 45 | 41 | 66 | 47 | 47 |
| ΔA1c | − 1.9 | − 0.9 | − 1.8 | − 1.1 | − 1.1 | − 0.6 |
| Final A1c (week 30) | 6.9 | 8.0 | 6.6 | 7.1 | 6.9 | 7.5 |
| Δ body weight (kg) | − 2.7 | 0.0 | − 1.4 | + 1.8 | − 0.7 | 0.7 |
| % A1c < 7% | 60 | 23 | 72 | 47 | 34 | 13 |
| A1c < 7% without weight gain (%) | NA | NA | 50 | 20 | 34 | 13 |
| A1c < 7% without hypoglycemia (%) | NA | NA | 54 | 29 | 32 | 19 |
| A1c < 7% without weight gain or hypoglycemia (%) | 40 | 8 | 39 | 12 | 20 | 9 |
| Hypoglycemia (%)a | 24 | 25 | 28 | 49 | 40 | 42 |
aDifferent definitions for hypoglycaemia were used in the two studies. For the DUAL 2 and 5 trials, confirmed hypoglycaemia was defined as the occurrence of episodes requiring assistance (severe), or episodes in which plasma glucose concentration (determined from self-monitored blood glucose) was less than 56 mg/dL, irrespective of symptoms. For the LixiLan-L trial, documented symptomatic hypoglycemia was defined as typical symptoms of hypoglycaemia accompanied by a measured plasma glucose concentration of #70 mg/dL