Baseline demographics and medications
. | Liraglutide 3.0 mg (n = 198) . | Placebo (n = 198) . |
---|---|---|
Male sex, n (%) | 90 (45.5) | 99 (50.0) |
Mean age, years (SD) | 55.9 (11.3) | 57.6 (10.4) |
Race, n (%) | ||
White | 174 (87.9) | 180 (90.9) |
Black | 17 (8.6) | 11 (5.6) |
Asian | 3 (1.5) | 5 (2.5) |
Ethnicity not Hispanic or Latino, n (%) | 155 (78.3) | 169 (85.4) |
Mean body weight, kg (SD)* | 100.6 (20.8) | 98.9 (19.9) |
Mean BMI, kg/m2 (SD) | 35.9 (6.5) | 35.3 (5.8) |
Mean waist circumference, cm (SD) | 114.8 (13.7) | 114.2 (13.2) |
Mean HbA1c, % (SD) | 7.9 (1.1) | 8 (1.0) |
Mean HbA1c, mmol/mol (SD) | 63.0 (11.5) | 63.6 (11.3) |
Mean FPG, mmol/L (SD) | 7.8 (2.2) | 8.1 (2.5) |
Mean FPG, mg/dL (SD) | 141 (40) | 146 (46) |
Mean diabetes duration, years (SD) | 11.4 (6.8) | 12.8 (6.9) |
Mean heart rate, bpm (SD)† | 74.0 (10.0) | 75.0 (11.0) |
Mean SBP, mmHg (SD) | 129.0 (14.0) | 132.0 (16.0) |
Mean DBP, mmHg (SD) | 78.0 (9.0) | 78.0 (9.0) |
Mean total cholesterol, mmol/L (SD) | 4.5 (1.0) | 4.4 (0.9) |
Mean total cholesterol, mg/dL (SD) | 172 (39) | 171 (36) |
Mean LDL cholesterol, mmol/L (SD) | 2.4 (0.9) | 2.4 (0.8) |
Mean LDL cholesterol, mg/dL (SD) | 94 (33) | 94 (29) |
Mean HDL cholesterol, mmol/L (SD) | 1.2 (0.3) | 1.2 (0.3) |
Mean HDL cholesterol, mg/dL (SD) | 45 (12) | 45 (11) |
Mean VLDL cholesterol, mmol/L (SD) | 0.9 (0.4) | 0.8 (0.4) |
Mean VLDL cholesterol, mg/dL (SD) | 33 (16) | 32 (15) |
Mean triglycerides, mmol/L (SD) | 2.0 (1.2) | 1.9 (1.0) |
Mean triglycerides, mg/dL (SD) | 174 (105) | 168 (89) |
Mean free fatty acids, mmol/L (SD) | 0.6 (0.2) | 0.6 (0.3) |
Mean free fatty acids, mg/dL (SD) | 15.9 (6.9) | 15.5 (7.3) |
Antidiabetic medications at screening, n (%) | ||
Biguanides | 175 (88.4) | 176 (88.9) |
SUs | 68 (34.3) | 71 (35.9) |
SGLT2i | 44 (22.2) | 44 (22.2) |
Thiazolidinediones | 4 (2.0) | 6 (3.0) |
Combination BG-lowering drugs (oral) | 4 (2.0) | 3 (1.5) |
α-Glucosidase inhibitors | 2 (1.0) | 0 (0.0) |
Other BG-lowering drugs, excluding insulins | 1 (0.5) | 5 (2.5) |
Insulins/analogs (injection), n (%) | ||
Long-acting | 180 (90.9) | 184 (92.9) |
Intermediate-acting | 18 (9.1) | 14 (7.1) |
. | Liraglutide 3.0 mg (n = 198) . | Placebo (n = 198) . |
---|---|---|
Male sex, n (%) | 90 (45.5) | 99 (50.0) |
Mean age, years (SD) | 55.9 (11.3) | 57.6 (10.4) |
Race, n (%) | ||
White | 174 (87.9) | 180 (90.9) |
Black | 17 (8.6) | 11 (5.6) |
Asian | 3 (1.5) | 5 (2.5) |
Ethnicity not Hispanic or Latino, n (%) | 155 (78.3) | 169 (85.4) |
Mean body weight, kg (SD)* | 100.6 (20.8) | 98.9 (19.9) |
Mean BMI, kg/m2 (SD) | 35.9 (6.5) | 35.3 (5.8) |
Mean waist circumference, cm (SD) | 114.8 (13.7) | 114.2 (13.2) |
Mean HbA1c, % (SD) | 7.9 (1.1) | 8 (1.0) |
Mean HbA1c, mmol/mol (SD) | 63.0 (11.5) | 63.6 (11.3) |
Mean FPG, mmol/L (SD) | 7.8 (2.2) | 8.1 (2.5) |
Mean FPG, mg/dL (SD) | 141 (40) | 146 (46) |
Mean diabetes duration, years (SD) | 11.4 (6.8) | 12.8 (6.9) |
Mean heart rate, bpm (SD)† | 74.0 (10.0) | 75.0 (11.0) |
Mean SBP, mmHg (SD) | 129.0 (14.0) | 132.0 (16.0) |
Mean DBP, mmHg (SD) | 78.0 (9.0) | 78.0 (9.0) |
Mean total cholesterol, mmol/L (SD) | 4.5 (1.0) | 4.4 (0.9) |
Mean total cholesterol, mg/dL (SD) | 172 (39) | 171 (36) |
Mean LDL cholesterol, mmol/L (SD) | 2.4 (0.9) | 2.4 (0.8) |
Mean LDL cholesterol, mg/dL (SD) | 94 (33) | 94 (29) |
Mean HDL cholesterol, mmol/L (SD) | 1.2 (0.3) | 1.2 (0.3) |
Mean HDL cholesterol, mg/dL (SD) | 45 (12) | 45 (11) |
Mean VLDL cholesterol, mmol/L (SD) | 0.9 (0.4) | 0.8 (0.4) |
Mean VLDL cholesterol, mg/dL (SD) | 33 (16) | 32 (15) |
Mean triglycerides, mmol/L (SD) | 2.0 (1.2) | 1.9 (1.0) |
Mean triglycerides, mg/dL (SD) | 174 (105) | 168 (89) |
Mean free fatty acids, mmol/L (SD) | 0.6 (0.2) | 0.6 (0.3) |
Mean free fatty acids, mg/dL (SD) | 15.9 (6.9) | 15.5 (7.3) |
Antidiabetic medications at screening, n (%) | ||
Biguanides | 175 (88.4) | 176 (88.9) |
SUs | 68 (34.3) | 71 (35.9) |
SGLT2i | 44 (22.2) | 44 (22.2) |
Thiazolidinediones | 4 (2.0) | 6 (3.0) |
Combination BG-lowering drugs (oral) | 4 (2.0) | 3 (1.5) |
α-Glucosidase inhibitors | 2 (1.0) | 0 (0.0) |
Other BG-lowering drugs, excluding insulins | 1 (0.5) | 5 (2.5) |
Insulins/analogs (injection), n (%) | ||
Long-acting | 180 (90.9) | 184 (92.9) |
Intermediate-acting | 18 (9.1) | 14 (7.1) |
DBP, diastolic blood pressure; SBP, systolic blood pressure; SGLT2i, sodium–glucose cotransporter 2 inhibitor.
Body weight measurements include both fasting and nonfasting measures.
Safety analysis set; liraglutide, n = 195; placebo, n = 197.