Baseline demographics and clinical characteristics (STEP 2)
| . | Semaglutide 1.0 mg (n = 403) . | Semaglutide 2.4 mg (n = 404) . | Placebo (n = 403) . |
|---|---|---|---|
| Age, years, mean (SD) | 56 (10) | 55 (11) | 55 (11) |
| Sex | |||
| Male | 200 (49.6) | 181 (44.8) | 213 (52.9) |
| Female | 203 (50.4) | 223 (55.2) | 190 (47.1) |
| Race | |||
| American Indian or Alaska Native | 0 | 4 (1.0) | 2 (0.5) |
| Asian | 97 (24.1) | 112 (27.7) | 108 (26.8) |
| Black or African American | 28 (6.9) | 35 (8.7) | 37 (9.2) |
| White | 272 (67.5) | 237 (58.7) | 242 (60.0) |
| Other | 6 (1.5) | 16 (4.0) | 13 (3.2) |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 (0.2) |
| Duration of diabetes, years [no.*], mean (SD) | 7.7 (5.9) | 8.2 (6.2) | 8.2 (6.2) [402] |
| HbA1c, mmol/mol, mean (SD) | 65.4 (8.5) | 65.3 (8.7) | 65.3 (9.0) |
| HbA1c, % | 8.1 (0.8) | 8.1 (0.8) | 8.1 (0.8) |
| Body weight, kg, mean (SD) | 99.0 (21.1) | 99.9 (22.5) | 100.5 (20.9) |
| BMI, kg/m2, mean (SD) | 35.3 (5.9) | 35.9 (6.4) | 35.9 (6.5) |
| eGFR, CKD-EPI, mL/min/1.73 m2 | |||
| Mean (SD) | 95.4 (18.1) | 96.3 (18.5) | 94.6 (19.3) |
| Distribution† [no.*] | [402] | [403] | [402] |
| ≥90 | 265 (65.9) | 270 (67.0) | 259 (64.4) |
| <90 | 137 (34.1) | 133 (33.0) | 143 (35.6) |
| UACR, mg/g† [no.*] | [402] | [403] | [402] |
| Geometric mean (CV) | 13.7 (249.6) | 12.5 (225.1) | 13.2 (199.8) |
| Normal albuminuria (UACR <30) | 306 (77.5) | 318 (80.5) | 317 (79.4) |
| Microalbuminuria (UACR ≥30 to <300) | 72 (18.2) | 64 (16.2) | 71 (17.8) |
| Macroalbuminuria (UACR ≥300) | 17 (4.3) | 13 (3.3) | 11 (2.8) |
| Blood pressure, mmHg, mean (SD) | |||
| Systolic blood pressure | 130 (14) | 130 (13) | 130 (13) |
| Diastolic blood pressure | 80 (9) | 80 (9) | 80 (9) |
| History of CV | 90 (22.3) | 58 (14.4) | 69 (17.1) |
| SGLT2 inhibitor use | 90 (22.3) | 95 (23.5) | 99 (24.6) |
| Agents acting on the RAS | 244 (60.5) | 216 (53.5) | 241 (59.8) |
| . | Semaglutide 1.0 mg (n = 403) . | Semaglutide 2.4 mg (n = 404) . | Placebo (n = 403) . |
|---|---|---|---|
| Age, years, mean (SD) | 56 (10) | 55 (11) | 55 (11) |
| Sex | |||
| Male | 200 (49.6) | 181 (44.8) | 213 (52.9) |
| Female | 203 (50.4) | 223 (55.2) | 190 (47.1) |
| Race | |||
| American Indian or Alaska Native | 0 | 4 (1.0) | 2 (0.5) |
| Asian | 97 (24.1) | 112 (27.7) | 108 (26.8) |
| Black or African American | 28 (6.9) | 35 (8.7) | 37 (9.2) |
| White | 272 (67.5) | 237 (58.7) | 242 (60.0) |
| Other | 6 (1.5) | 16 (4.0) | 13 (3.2) |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 (0.2) |
| Duration of diabetes, years [no.*], mean (SD) | 7.7 (5.9) | 8.2 (6.2) | 8.2 (6.2) [402] |
| HbA1c, mmol/mol, mean (SD) | 65.4 (8.5) | 65.3 (8.7) | 65.3 (9.0) |
| HbA1c, % | 8.1 (0.8) | 8.1 (0.8) | 8.1 (0.8) |
| Body weight, kg, mean (SD) | 99.0 (21.1) | 99.9 (22.5) | 100.5 (20.9) |
| BMI, kg/m2, mean (SD) | 35.3 (5.9) | 35.9 (6.4) | 35.9 (6.5) |
| eGFR, CKD-EPI, mL/min/1.73 m2 | |||
| Mean (SD) | 95.4 (18.1) | 96.3 (18.5) | 94.6 (19.3) |
| Distribution† [no.*] | [402] | [403] | [402] |
| ≥90 | 265 (65.9) | 270 (67.0) | 259 (64.4) |
| <90 | 137 (34.1) | 133 (33.0) | 143 (35.6) |
| UACR, mg/g† [no.*] | [402] | [403] | [402] |
| Geometric mean (CV) | 13.7 (249.6) | 12.5 (225.1) | 13.2 (199.8) |
| Normal albuminuria (UACR <30) | 306 (77.5) | 318 (80.5) | 317 (79.4) |
| Microalbuminuria (UACR ≥30 to <300) | 72 (18.2) | 64 (16.2) | 71 (17.8) |
| Macroalbuminuria (UACR ≥300) | 17 (4.3) | 13 (3.3) | 11 (2.8) |
| Blood pressure, mmHg, mean (SD) | |||
| Systolic blood pressure | 130 (14) | 130 (13) | 130 (13) |
| Diastolic blood pressure | 80 (9) | 80 (9) | 80 (9) |
| History of CV | 90 (22.3) | 58 (14.4) | 69 (17.1) |
| SGLT2 inhibitor use | 90 (22.3) | 95 (23.5) | 99 (24.6) |
| Agents acting on the RAS | 244 (60.5) | 216 (53.5) | 241 (59.8) |
Data are n (%) and are for the full analysis set unless otherwise indicated. n is number of patients. Novo Nordisk data published in Davies M, Færch L, Jeppesen OK, et al. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet 2021;397:971–984.
CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; CV, coefficient of variation.
[no.] is number of participants analyzed (where different from the number in the full analysis set).
Data are for the safety analysis set.