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TABLE 1.

Phase 3 Clinical Trials With IDegLira and iGlarLixi in Patients With Type 2 Diabetes

Patient PopulationnMean 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 
Patient PopulationnMean 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.

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