Table 1

Patient demographics and baseline characteristics by treatment group (safety population)

AlbiglutideSitagliptinTotalP*
N249246495
Severity of renal impairment, n (%)0.9522
 Mild128 (51.4)128 (52.0)256 (51.7)
 Moderate102 (41.0)101 (41.1)203 (41.0)
 Severe19 (7.6)17 (6.9)36 (7.3)
Age (years), mean (SD)63.2 (8.37)63.5 (9.02)63.3 (8.69)0.733
 <65141 (56.6)138 (56.1)279 (56.4)0.906
 ≥65108 (43.4)108 (43.9)216 (43.6)
Sex, n (%)0.692
 Female113 (45.4)116 (47.2)229 (46.3)
 Male136 (54.6)130 (52.8)266 (53.7)
Race, n (%)
 Black36 (14.5)42 (17.1)78 (15.8)
 Asian84 (33.7)76 (30.9)160 (32.3)
 White113 (45.4)114 (46.3)227 (45.8)
 Other17 (6.8)16 (6.5)33 (6.7)
Diabetes duration (years), mean (SD)10.83 (7.403)11.62 (8.476)11.23 (7.956)0.271
Baseline HbA1c, mean (SD)8.13 (1.036)8.23 (0.942)8.18 (0.991)0.247
 <8.0% (<63.9 mmol/mol)131 (52.6)107 (43.5)238 (48.1)0.042
 ≥8.0% (≥63.9 mmol/mol)118 (47.4)139 (56.5)257 (51.9)
Prior myocardial infarction, n (%)0.841
 Yes21 (8.4)22 (8.9)43 (8.7)
 No228 (91.6)224 (91.1)452 (91.3)
Body weight (kg), mean (SD)83.25 (19.902)82.84 (20.649)83.04 (20.275)0.821
BMI (kg/m2), mean (SD)30.35 (5.466)30.43 (5.828)30.39 (5.644)0.873
Baseline vital signs, mean (SD)
 Systolic blood pressure (mmHg)132.9 (14.78)132.8 (14.94)132.9 (14.87)0.940
 Diastolic blood pressure (mmHg)78.5 (10.34)78.8 (9.17)78.6 (9.79)0.733
Baseline lipids, mean (SD)
 Total cholesterol (mmol/L)4.7 (1.21)4.5 (1.08)4.6 (1.15)0.053
 HDL (mmol/L)1.2 (0.32)1.2 (0.32)1.2 (0.32)1.000
 LDL (mmol/L)2.5 (0.95)2.4 (0.95)2.5 (0.95)0.245
 Triglycerides (mmol/L)2.3 (1.64)2.0 (0.97)2.2 (1.36)0.014
Patients with any diabetes condition^, n (%)
 Dyslipidemia177 (71.1)172 (69.9)349 (70.5)0.776
 Nephropathy66 (26.5)61 (24.8)127 (25.7)0.663
 Peripheral neuropathy62 (24.9)58 (23.6)120 (24.2)0.731
 Diabetic retinopathy40 (16.1)49 (19.9)89 (18.0)0.264
  • *The P value was for testing the null hypothesis that the population values (mean or proportion) were equal between the two treatment groups (albiglutide and sitagliptin). All tests were two-sided.

  • †Patients could be counted in more than one race category. A P value was not calculated for race.

  • ^Diabetes conditions were not predefined in the protocol but were investigator assessed.