TABLE 1.
Phase 3 Clinical Trials With IDegLira and iGlarLixi in Patients With Type 2 Diabetes
| Patient Population | n | Mean A1C at Baseline (%) | A1C Change From Baseline (%) | Patients Achieving an A1C <7.0% (%) | Body Weight Change From Baseline (kg) | Hypoglycemia (%)* | |
|---|---|---|---|---|---|---|---|
| iGlarLixi studies | |||||||
| LixiLan-O (33) | Insulin-naive; metformin ± another OAD | iGlarLixi: 469 iGlar: 467 Lixi: 234 |
iGlarLixi: 8.1 iGlar: 8.1 Lixi: 8.1 |
Run-in: –0.1 iGlarLixi: –1.6§ iGlar: –1.3§ Lixi: –0.9§ |
iGlarLixi: 73.7 iGlar: 59.4 Lixi: 33.0 |
iGlarLixi: –0.3§ iGlar: +1.1§ Lixi: –2.3§ |
iGlarLixi: 25.6 iGlar: 23.6 Lixi: 6.4 |
| LixiLan-L (34) | Basal insulin ± up to 2 OADs | iGlarLixi: 367 iGlar: 369 |
iGlarLixi: 8.1 iGlar: 8.1 |
Run-in: –0.4 iGlarLixi: –1.1§ iGlar: –0.6§ |
iGlarLixi: 54.9 iGlar: 29.6 |
iGlarLixi: –0.7§ iGlar: +0.7§ |
iGlarLixi: 40.0 iGlar: 42.5 |
| IDegLira studies | |||||||
| DUAL I (35) | Insulin-naive; Metformin ± pioglitazone | IDegLira: 833 IDeg: 413 Lira: 414 |
IDegLira: 8.3 IDeg: 8.3 Lira: 8.3 |
IDegLira: –1.9 IDeg: –1.4 Lira: –1.3 |
IDegLira: 81 IDeg: 65 Lira: 60 |
IDegLira: –0.5 IDeg: +1.6 Lira: –3.0 |
IDegLira: 32 IDeg: 39 Lira: 7 |
| DUAL II (39) | Previous insulin + metformin ± another OAD | IDegLira: 199 IDeg: 199 |
IDegLira: 8.7 IDeg: 8.8 |
IDegLira: –1.9 IDeg: –0.9 |
IDegLira: 60 IDeg: 23 |
IDegLira: –2.7 IDeg: 0 |
IDegLira: 24 IDeg: 25 |
| DUAL III (36) | Previous GLP-1 RA + metformin ± another OAD | IDegLira: 292 GLP-1 RA: 146 |
IDegLira: 7.8 GLP-1 RA: 7.7 |
IDegLira: –1.3 GLP-1 RA: –0.3 |
IDegLira: 75 GLP-1 RA: 36 |
IDegLira: +2.0 GLP-1 RA: –0.8 |
IDegLira: 2.82 episodes/PYE† GLP-1 RA: 0.12 episodes/PYE† |
| DUAL IV (38) | Insulin-naive; sulfonylurea ± metformin | IDegLira: 289 Placebo: 146 |
IDegLira: 7.9 Placebo: 7.9 |
IDegLira: –1.5 Placebo: –0.5 |
IDegLira: 79.2 Placebo: 28.8 |
IDegLira: +0.5 Placebo: –1.0 |
IDegLira: 41.7 Placebo: 17.1 |
| DUAL V (37) | iGlar + metformin | IDegLira: 278 iGlar: 279 |
IDegLira: 8.4 iGlar: 8.2 |
IDegLira: –1.81 iGlar: –1.13 |
IDegLira: 71.6 iGlar: 47.0 |
IDegLira: –1.4 iGlar: +1.8 |
IDegLira: 28.4 iGlar: 49.1 |
| DUAL VII (40) | iGlar + metformin | IDegLira: 252 iGlar + insulin aspart: 254 |
IDegLira: 8.2 iGlar + insulin aspart: 8.2 |
IDegLira: –1.49 iGlar + insulin aspart: –1.48 |
IDegLira: 66.0 iGlar + insulin aspart: 67.0 |
IDegLira: –0.92 iGlar + insulin aspart: +2.64 |
IDegLira: 1.07 episodes/PYE† iGlar + insulin aspart: 8.17 episodes/PYE† |
*
DUAL studies, confirmed or severe hypoglycemia (<56 mg/dL); LixiLan studies, documented symptomatic hypoglycemia (≤70 mg/dL).
†
Incidence of hypoglycemia events (%) was not reported for this trial.
§
Least squares. GLP-1 RA, glucagon-like peptide-1 receptor agonist; IDeg, insulin degludec U100; iGlar, insulin glargine U100; Lira, liraglutide; Lixi, lixisenatide; PYE, patient-years of exposure.