Table 1.
DUAL I [12] |
DUAL II [53] |
DUAL III [55] |
DUAL IV [56] |
DUAL V [57] |
||
---|---|---|---|---|---|---|
IDegLira vs IDeg | IDegLira vs liraglutide | IDegLira vs IDeg | IDegLira vs unchanged GLP-1RA | IDegLira vs placebo | IDegLira vs insulin glargine | |
HbA1c change†, ETD, %-points | –0.47 (–0.58 to –0.36), p < 0.0001 (noninferior) |
–0.64 (–0.75 to –0.53), p < 0.0001 (superior) | –1.1 (–1.3 to –0.8), p < 0.0001 (superior) | –0.94 (–1.11 to –0.78), p < 0.001 (superior) | –1.02%, p < 0.001 | –0.59 (–0.74 to –0.45), p < 0.001 |
Fasting plasma glucose change†, ETD, mmol/l | –0.17 (–0.41 to 0.07), NS | –1.76 (–2.00 to –1.53), p < 0.0001 | –0.73 (–0.19 to –0.27), p = 0.0019 | –2.64 (–3.03 to –2.25), p < 0.001 | –2.30, p < 0.001 | –0.01 (–0.35 to –0.33), NS |
Mean of postprandial plasma glucose increment across all main meals, ETD, mmol/l |
–0.45 (–0.63 to –0.28), p < 0.0001 | 0.06 (–0.11 to 0.23), NS | –0.4 (–0.7 to –0.0) p = 0.0260 |
N/A | N/A | N/A |
Weight change†, ETD, kg | –2.22 (–2.64 to –1.80), p < 0.0001 | +2.44 (2.02–2.86), p < 0.0001 |
–2.5 (–3.2 to –1.8), p < 0.0001 |
2.89 (2.17–3.62], p < 0.001 |
N/A | –3.2 (–3.77 to –2.64), p < 0.001 |
Confirmed hypoglycemia‡, rate ratio | 0.68 (0.53 to 0.87), p = 0.0023 |
7.61 (5.17 to 11.21), p < 0.0001 |
0.66 (0.39 to 1.13), NS | 25.4 (10.6 to 60.5), p < 0.001 | 3.74, p < 0.001 |
0.43 (0.30 to 0.61), p < 0.001 |
Nocturnal confirmed hypoglycemia§, rate ratio | N/A | N/A | 0.81 (0.35 to 1.90), NS | N/A | N/A | 0.17 (0.10 to 0.31), p < 0.001 |
Daily insulin dose¶, ETD, U | –14.90 (–17.14 to 12.66), p < 0.0001 | N/A | 0.02 NS | N/A | N/A | 41 dose steps vs 66 U p < 0.001 |
Values in square brackets indicate 95% CIs.
† Change from baseline to end of trial (week 26).
‡ Confirmed with plasma glucose <3.1 mmol/l.
§Nocturnal confirmed hypoglycemia, plasma glucose <3.1 mmol/l occurring 00:01–05:59 inclusive.
¶ At week 26.
ETD: Estimated treatment difference; IDegLira: Insulin degludec/liraglutide; N/A: Not applicable/available; NS: Not significant.