Characteristic/variable | Exenatide (n = 247) | Lispro (n = 263) | Exenatide-lispro |
---|---|---|---|

Demographics | |||

Men | 128 (52%) | 133 (51%) | |

Age (years), mean (SD) | 59.5 (9.6) | 59.4 (9.3) | |

Duration of diabetes (years), median (IQR) | 12 (8–17) | 11 (8–15) | |

Ethnic origin | |||

White | 222 (90%) | 229 (87%) | |

Asian | 11 (5%) | 14 (5%) | |

African American | 2 (<1%) | 1 (<1%) | |

Other^{*} | 12 (5%) | 18 (7%) | |

Use of glucose-lowering agents | |||

Metformin daily dose (mg), mean (SD) | 2,038 (633) | 1,998 (648) | |

Previous sulfonylurea use | 85 (34%) | 99 (38%) | |

Insulin glargine (units/day) | |||

Randomization, mean (SD) | 61.5 (30.9) | 61.1 (35.2) | |

End point, mean (SD) | 56.9 (29.4) | 51.5 (31.4) | |

End point, LS mean (SE) (95% CI)^{†} | 56.8 (1.2) | 51.5 (1.2) | 5.3 (2.1, 8.5)^{‡} |

Randomization, median (IQR) | 54 (40–76) | 52 (38–76) | |

End point, median (IQR) | 50 (36–74) | 46 (34–62) | |

Insulin lispro (units/day) | |||

1 week, mean (SD) | — | 24.6 (12.7) | |

End point, mean (SD) | — | 42.1 (30.8) | |

1 week, median (IQR) | — | 22 (16–30) | |

End point, median (IQR) | — | 34 (24–52) | |

Insulin glargine + insulin lispro (units/day) | |||

1 week, mean (SD) | — | 64.0 (32.9) | |

End point, mean (SD) | — | 93.7 (53.9) | |

1 week, median (IQR) | — | 56 (42–80) | |

End point, median (IQR) | — | 82 (60–108) | |

Exenatide (μg/day) | |||

1 week, mean (SD) | 9.9 (0.8) | — | |

End point, mean (SD) | 18.6 (3.6) | — | |

Randomization, median (IQR) | 10 (10–10) | — | |

End point, median (IQR) | 20 (20–20) | — | |

Glycemic measures | |||

HbA_{1c} (%) [mmol/mol] | |||

Randomization, mean (SD) | 8.3 (1.0) [67 (11)] | 8.2 (0.9) [66 (10)] | |

End point, mean (SD) | 7.2 (1.0) [55 (11)] | 7.2 (1.0) [55 (11)] | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −1.13 (0.05) [–12.4 (0.5)] | −1.10 (0.05) [–12.0 (0.5)] | −0.04 (–0.18, 0.11) |

Patients with HbA_{1c} ≤7% (% [95% CI]) | 49.6 [42.6, 55.4] | 49.0 [42.9, 55.3] | |

Patients with HbA_{1c} ≤6.5% (% [95% CI]) | 26.2 [20.6, 31.8] | 25.5 [20.3, 31.2] | |

FG (mmol/L) | |||

Randomization, mean (SD) | 7.1 (2.3) | 7.1 (2.5) | |

End point, mean (SD) | 6.5 (2.0) | 7.2 (2.8) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −0.46 (0.16) | 0.18 (0.15) | −0.64 (–1.05, –0.24)^{§} |

Self-monitored blood glucose (mmol/L)^{¶} | |||

Morning 2 h postmeal | |||

Randomization, mean (SD) | 9.97 (2.94) | 10.21 (2.89) | |

End point, mean (SD) | 7.42 (1.97) | 7.74 (2.10) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −2.57 (0.14) | −2.30 (0.14) | −0.27 (–0.63, 0.09) |

Midday 2 h postmeal | |||

Randomization, mean (SD) | 10.4 (2.7) | 10.9 (3.0) | |

End point, mean (SD) | 8.5 (2.4) | 7.6 (2.2) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −2.18 (0.16) | −3.11 (0.16) | 0.93 (0.52, 1.34)^{‖} |

Evening 2 h postmeal | |||

Randomization, mean (SD) | 10.9 (3.2) | 11.1 (2.9) | |

End point, mean (SD) | 8.2 (2.6) | 7.8 (2.4) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −2.88 (0.17) | −3.16 (0.17) | 0.28 (–0.16, 0.72) |

1,5 anhydroglucitol (μg/mL)^{**} | |||

Randomization, median (IQR) | 5.7 (3.2–9.0) | 5.1 (2.9–9.1) | |

End point, median (IQR)^{††} | 9.8 (5.3–14.0) | 10.0 (5.5–15.4) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | 1.2 (3.0) | 5.3 (3.0) | −4.2 (–11.4, 3.1) |

Fasting glucagon (pmol/L) | |||

Randomization, mean (SD) | 24.8 (10.1) | 24.3 (9.2) | |

End point, mean (SD) | 25.6 (12.0) | 24.3 (10.1) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | 1.3 (0.7) | 0.3 (0.7) | 1.1 (–0.6, 2.7) |

Weight and composite measures | |||

BMI (kg/m^{2}) | |||

Randomization, mean (SD) | 32.7 (4.7) | 32.3 (4.7) | |

End point, mean (SD) | 31.8 (4.6) | 33.1 (5.1) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −0.9 (0.1) | 0.8 (0.1) | −1.7 (–1.9, –1.4)^{‖} |

Body weight (kg) | |||

Randomization, mean (SD) | 91.1 (16.6) | 89.4 (17.0) | |

End point, mean (SD) | 88.6 (16.5) | 91.4 (17.9) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −2.5 (0.3) | 2.1 (0.2) | −4.6 (–5.2, −3.9)^{‖} |

Waist circumference (cm) | |||

Randomization, mean (SD) | 108 (13) | 108 (13) | |

End point, mean (SD) | 106 (13) | 108 (14) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −2.0 (0.4) | 0.7 (0.3) | −2.7 (–3.6, –1.8)^{‖} |

Hip circumference (cm) | |||

Randomization, mean (SD) | 110 (12) | 110 (11) | |

End point, mean (SD) | 109 (11) | 111 (12) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −1.8 (0.4) | 0.9 (0.4) | −3.0 (–3.6, –1.9)^{‖} |

HbA_{1c} ≤7% and ≤1 kg weight gain (% [95% CI]) | 44.6 [37.4, 50.2] | 22.9 [17.9, 28.4]ǁ | |

HbA_{1c} ≤6.5% and ≤1 kg weight gain (% [95% CI]) | 23.1 [17.6, 28.4] | 14.5 [10.4, 19.3]^{§§} | |

Cardiovascular parameters | |||

Systolic blood pressure (mmHg) | |||

Randomization, mean (SD) | 137 (16) | 135 (15) | |

End point, mean (SD) | 133 (14) | 136 (16) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −4.1 (1.0) | 0.4 (0.9) | −4.5 (–7.0, –2.0)^{‖} |

Diastolic blood pressure (mmHg) | |||

Randomization, mean (SD) | 79 (10) | 78 (9) | |

End point, mean (SD) | 79 (10) | 79 (10) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | −0.6 (0.6) | −0.1 (0.6) | −0.5 (–2.1, 1.1) |

Pulse rate (beats per min) | |||

Randomization, mean (SD) | 74 (11) | 73 (10) | |

End point, mean (SD) | 75 (11) | 74 (11) | |

Change from randomization, LS mean (SE) (95% CI)^{†} | 1.5 (0.6) | 0.9 (0.6) | 0.6 (–1.1, 2.2) |

Cholesterol (mmol/L) | |||

Total cholesterol | |||

Randomization, mean (SD) | 4.6 (1.0) | 4.6 (1.0) | |

End point, mean (SD) | 4.5 (1.0) | 4.6 (1.1) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | −0.1 (0.1) | −0.0 (0.0) | −0.1 (–0.2, 0.0) |

LDL cholesterol | |||

Randomization, mean (SD) | 2.5 (0.8) | 2.6 (0.9) | |

End point, mean (SD) | 2.5 (0.8) | 2.6 (0.9) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | −0.1 (0.0) | −0.0 (0.0) | −0.1 (–0.2, 0.0) |

HDL cholesterol | |||

Randomization, mean (SD) | 1.2 (0.3) | 1.2 (0.3) | |

End point, mean (SD) | 1.2 (0.3) | 1.2 (0.3) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | −0.04 (0.01) | 0.03 (0.01) | −0.07 (–0.10, –0.04)^{‖} |

Triglycerides (mmol/L) | |||

Randomization, median (IQR) | 1.6 (1.2–2.1) | 1.5 (1.1–2.0) | |

End point, median (IQR) | 1.6 (1.2–2.3) | 1.4 (1.1–2.0) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | 0.06 (0.06) | −0.05 (0.06) | 0.11 (–0.03, 0.24) |

Adiponectin (ng/L)^{**} | |||

Randomization, median (IQR) | 5,771 (3,957–7,737) | 5,406 (3,869–7,778) | |

End point, median (IQR) | 6,061 (4,103–8,581) | 5,201 (3,541–7,985) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | −491 (247) | −651 (249) | 160 (–430, 750) |

hs-CRP (mg/L)^{**} | |||

Randomization, mean (SD) | 4.9 (5.7) | 4.5 (5.9) | |

End point, mean (SD)^{††} | 4.3 (6.6) | 4.9 (6.5) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | −0.6 (0.4) | 0.2 (0.4) | −0.8 (–1.7, 0.1) |

Randomization, median (IQR) | 3.2 (1.5–6.2) | 2.6 (1.3–5.4) | |

End point, median (IQR) | 2.7 (1.1–5.3) | 2.7 (1.1–5.9) | |

Urine albumin/creatinine (mg/mmol)^{**} | |||

Randomization, median (IQR) | 1.6 (0.6–5.0) | 1.4 (0.6–5.2) | |

End point, median (IQR)^{††} | 1.1 (0.5–2.9) | 1.2 (0.5–5.2) | |

Change from randomization, LS mean (SE) (95% CI)^{‡‡} | −4.2 (2.6) | −3.7 (2.6) | −0.5 (–6.7, 5.7) |

All values are for the PP population unless otherwise noted. LS, least squares.

↵*American Indian or Native Alaskan.

↵†Calculated using MMRM.

↵‡

*P*= 0.001.↵§

*P*= 0.002.↵¶From self-monitored blood glucose profiles.

↵‖

*P*< 0.001.↵**ITT population.

↵††End point values are last observation carried forward.

↵‡‡Calculated using ANCOVA at end point for change from randomization.

↵§§

*P*= 0.005.