TABLE 1.
Characteristics of patients with residual hyperglycaemia (HbA1c ≥ 7.0% and FPG < 140 mg/dL) in the LixiLan‐L study at baseline (A) and week 30 (B)
| (A) | |||
|---|---|---|---|
| Characteristics at baseline | iGlarLixi (N = 229) | iGlar (N = 227) | P‐value |
| Age | 59.4 (9.4) | 60.0 (8.5) | .4187 |
| Race, n (%) | |||
| White | 205 (89.5) | 203 (89.4) | .9777 |
| Black | 13 (5.7) | 18 (7.9) | |
| Asian | 10 (4.4) | 5 (2.2) | |
| Other | 1 (0.4) | 1 (0.4) | |
| Ethnicity, n (%) | |||
| Hispanic | 56 (24.5) | 41 (18.1) | .0957 |
| Not Hispanic | 173 (75.5) | 186 (81.9) | |
| Body weight, kg | 86.45 (14.05) | 87.19 (14.93) | .5870 |
| BMI, kg/m2 | 30.99 (4.17) | 30.98 (4.28) | .9705 |
| T2D duration, y | 12.46 (6.72) | 12.17 (6.84) | .6551 |
| Duration of baseline insulin treatment, y | 3.22 (3.13) | 3.35 (3.17) | .6704 |
| Insulin dose, U | 35.26 (9.52) | 35.34 (8.70) | .9281 |
| OAD use at screening, n (%) | |||
| None | 16 (7.0) | 11 (4.8) | .6707 |
| Metformin | 201 (87.8) | 206 (90.7) | |
| Others | 12 (5.2) | 10 (4.4) | |
| HbA1c, % | 8.07 (0.65) | 8.06 (0.68) | .9068 |
| FPG, mg/dL | 111.77 (19.46) | 111.56 (19.05) | .9093 |
| 2‐h PPG, mg/dL | 256.80 (67.58) | 265.57 (64.87) | .1602 |
| B | ||||
|---|---|---|---|---|
| Changes from baseline at week 30 | iGlarLixi (N = 229) | iGlar (N = 227) | LS mean difference | P‐value |
| HbA1c, % | 6.9 (0.9) | 7.5 (0.9) | ||
| Change | −1.2 (0.1) | −0.7 (0.1) | −0.6 (0.1) | <.0001 |
| FPG, mg/dL | 115.1 (37.8) | 116.8 (36.3) | ||
| Change | 7.1 (4.2) | 9.5 (4.2) | −2.4 (3.7) | .5091 |
| Body weight, kg | 86.1 (13.9) | 88.1 (15.4) | ||
| Change | −0.7 (0.3) | 0.9 (0.3) | −1.5 (0.3) | <.0001 |
| 2‐h PPG, mg/dL | 167.2 (62.0) | 240.8 (69.0) | ||
| Change | −87.4 (7.3) | −15.8 (7.2) | −71.6 (6.3) | <.0001 |
| Insulin dose, U | 45.3 (12.6) | 45.8 (12.7) | ||
| Change | 8.6 (1.1) | 9.6 (1.1) | −1.0 (1.0) | .3052 |
| % of patients with clinically significant hypoglycaemia (<54 mg/dL) | 17.9 | 12.8 | .1377 | |
| % of patients with nausea/vomiting | 11.4 | 1.8 | <.0001 | |
| % of patients with diarrhoea/nausea/vomiting | 12.7 | 4.4 | .0019 |
Abbreviations: BMI, body mass index; FPG, fasting plasma glucose; iGlar, insulin glargine Gla‐100; iGlarLixi, fixed‐ratio combination of insulin glargine and lixisenatide; LS, least squares; N, number of patients analysed; n, number of patients in each category; OAD, oral antidiabetes drug; PPG, postprandial plasma glucose; SE, standard error; T2D, type 2 diabetes; U, units.
All data are change from baseline, LS mean (SE) unless stated otherwise.