Table 2

Characteristics and results of patients at randomization and at study end point

Characteristic/variableExenatide (n = 247)Lispro (n = 263)Exenatide-lispro
Demographics
 Men128 (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
  White222 (90%)229 (87%)
  Asian11 (5%)14 (5%)
  African American2 (<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 use85 (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
 HbA1c (%) [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 HbA1c ≤7% (% [95% CI])49.6 [42.6, 55.4]49.0 [42.9, 55.3]
 Patients with HbA1c ≤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/m2)
  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)
 HbA1c ≤7% and ≤1 kg weight gain (% [95% CI])44.6 [37.4, 50.2]22.9 [17.9, 28.4]ǁ
 HbA1c ≤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.