TABLE 1.
| Population Characteristics | A1C Change From Baseline (%) | Patients Achieving A1C <7.0% (%) | Body Weight Change From Baseline (kg) | Patients With Hypoglycemia* (%) | Patients With GI Side Effects† (%) | |
|---|---|---|---|---|---|---|
| iGlarLixi | ||||||
| LixiLan-O n = 1,170 | Inadequately controlled on metformin ± a second oral antidiabetic agent | iGlarLixi: –1.6 | iGlarLixi: 73.7 | iGlarLixi: –0.3 | iGlarLixi: 25.6 | iGlarLixi: 21.7 |
| iGlar: –1.3‡ | iGlar: 59.4‡ | iGlar: +1.1‡ | iGlar: 23.6§ | iGlar: 12.6§ | ||
| Duration: 30 weeks | Mean age: 58.4 years | Lixi: –0.9‡ | Lixi: 33.0‡ | Lixi: –2.3 | Lixi: 6.4§ | Lixi: 36.9§ |
| Mean BMI: 31.7 kg/m2 | ||||||
| Mean duration of diabetes: 8.8 years | ||||||
| Mean A1C at baseline: 8.1% | ||||||
| LixiLan-L n = 736 | Inadequately controlled on basal insulin ± 1–2 OADs | iGlarLixi: –1.1 | iGlarLixi: 54.9 | iGlarLixi: –0.7 | iGlarLixi: 40.0 | iGlarLixi: 17.0 |
| iGlar: –0.6‡ | iGlar: 29.6‡ | iGlar: +0.7‡ | iGlar: 42.5§ | iGlar: 7.9§ | ||
| Duration: 30 weeks | Median age: 60.0 years | |||||
| Mean BMI: 31.2 kg/m2 | ||||||
| Mean duration of diabetes: 12.1 years | ||||||
| Mean A1C at baseline: 8.1% | ||||||
| IDegLira | ||||||
| DUAL I n = 1,663 | Previously treated with metformin ± pioglitazone | IDegLira: –1.9 | IDegLira: 80.6 | IDegLira: –0.5 | IDegLira: 31.9 | IDegLira: 3.9–8.8 |
| IDeg: –1.4ǁ | IDeg: 65.1‡ | IDeg: +1.6‡ | IDeg: 38.6§ | IDeg: 1.5–4.6§ | ||
| Duration: 26 weeks | Mean age: 55.0 years | Lira: –1.3‡ | Lira: 60.4‡ | Lira: –3.0‡ | Lira: 6.8§ | Lira: 8.5–19.7§ |
| Mean BMI: 31.2 kg/m2 | ||||||
| Mean duration of diabetes: 6.9 years | ||||||
| Mean A1C at baseline: 8.3% | ||||||
| DUAL II n = 413 | Inadequately controlled on basal insulin + metformin ± sulfonylurea or glinides | IDegLira: –1.9 | IDegLira: 60.3 | IDegLira: –2.7 | IDegLira: 24.1 | IDegLira: <2–6.5 |
| IDeg: –0.9‡ | IDeg: 23.1‡ | IDeg: 0‡ | IDeg: 24.6 | IDeg: 0–3.5§ | ||
| Duration: 26 weeks | Mean age: 57.5 years | |||||
| Mean BMI: 33.7 kg/m2 | ||||||
| Mean duration of diabetes: 10.5 years | ||||||
| Mean A1C at baseline: 8.8% | ||||||
| DUAL III n = 438 | Inadequately controlled with a GLP-1RA and OADs | IDegLira: –1.3 | IDegLira: 75 | IDegLira: +2.0 | IDegLira: 32.0 | IDegLira: 3.1 |
| U GLP-1RA: | U GLP-1RA: 36‡ | U GLP-1RA: | U GLP-1RA: 2.8‡ | U GLP-1RA: 4.1§ | ||
| Duration: 26 weeks | (metformin ± pioglitazone | –0.3‡ | –0.8‡ | |||
| ± sulfonylurea) | ||||||
| Mean age: 58.4 years | ||||||
| Mean BMI: 33.0 kg/m2 | ||||||
| Mean duration of diabetes: 10.4 years | ||||||
| Mean A1C at baseline: 7.8% | ||||||
| DUAL IV n = 435 | Inadequately controlled on metformin ± sulfonylureas | IDegLira: –1.5 | IDegLira: 79.2 | IDegLira: +0.5 | IDegLira: 41.7 | Not reported as one of the most frequently occurring adverse events |
| Placebo: –0.5‡ | Placebo: 28.8‡ | Placebo: –1.0‡ | Placebo: 17.1‡ | |||
| Duration: 26 weeks | Mean age: 59.7 years | |||||
| Mean BMI: 31.6 kg/m2 | ||||||
| Mean duration of diabetes: 9.2 years | ||||||
| Mean A1C at baseline: 7.9% | ||||||
| DUAL V n = 557 | Inadequately controlled on insulin glargine and metformin | IDegLira: –1.8 | IDegLira: 71.6 | IDegLira: –1.4 | IDegLira: 28.4 | IDegLira: 9.4 |
| iGlar: –1.1‡ | iGlar: 47.0‡ | iGlar: +1.8‡ | iGlar: 49.1‡ | iGlar: 1.1§ | ||
| Duration: 26 weeks | Mean age: 58.8 years | |||||
| Mean BMI: 31.7 kg/m2 | ||||||
| Mean duration of diabetes: 11.5 years | ||||||
| Mean A1C at baseline: 8.3% | ||||||
*
LixiLan trials, symptomatic and blood glucose ≤70 mg/dL; DUAL trials, requiring assistance or blood glucose <56 mg/dL.
†
GI side effects include nausea, vomiting, and/or diarrhea; not defined or reported similarly in each study.
‡
Statistically significant with comparator(s).
§
Did not report or unknown whether statistical significant was determined.
ǁ
Met noninferiority.
GLP-1RA, GLP-1 receptor agonist; IDeg, insulin degludec; iGlar, insulin glargine; Lira, liraglutide; Lixi, lixisenatide; U, unchanged.