Table 1. Baseline Demographics and Clinical Characteristics.
Characteristic | Mean (SD) | ||||
---|---|---|---|---|---|
Tirzepatide | Insulin lispro (n = 708) | ||||
15 mg (n = 236) | 10 mg (n = 238) | 5 mg (n = 243) | Pooled (n = 717) | ||
Age, y | 58.2 (9.6) | 59.6 (9.4) | 58.0 (10.2) | 58.6 (9.8) | 59.0 (9.7) |
Women, No. (%) | 133 (56.4) | 149 (62.6) | 144 (59.3) | 426 (59.4) | 396 (55.9) |
Men, No. (%) | 103 (43.6) | 89 (37.4) | 99 (40.7) | 291 (40.6) | 312 (44.1) |
Race, No. (%)a | |||||
American Indian or Alaska Native | 1 (0.4) | 0 | 0 | 1 (0.1) | 2 (0.3) |
Asian | 2 (0.8) | 0 | 2 (0.8) | 4 (0.6) | 4 (0.6) |
Black or African American | 11 (4.7) | 9 (3.8) | 11 (4.5) | 31 (4.3) | 26 (3.7) |
Multiple | 2 (0.8) | 5 (2.1) | 0 | 7 (1.0) | 8 (1.1) |
White | 220 (93.2) | 224 (94.1) | 230 (94.7) | 674 (94.0) | 668 (94.4) |
Hispanic or Latino, No. (%)a | 149 (63.1) | 142 (59.7) | 148 (60.9) | 439 (61.2) | 443 (62.6) |
Diabetes duration, yb | 13.4 (7.6) | 13.9 (7.3) | 13.4 (6.9) | 13.6 (7.2) | 14.0 (7.4) |
Body weight, kg | 91.2 (18.7) | 89.1 (18.8) | 91.7 (17.9) | 90.7 (18.5) | 90.3 (17.7) |
BMI | 33.0 (5.3) | 33.4 (5.5) | 33.5 (5.3) | 33.3 (5.4) | 33.0 (5.2) |
Use of metformin, No. (%) | 201 (85.2) | 195 (81.9) | 202 (83.1) | 598 (83.4) | 606 (85.6) |
Daily insulin glargine dose, median (IQR), IU | 47.0 (36.0-61.0) | 46.0 (34.0-60.0) | 46.0 (36.0-60.0) | 46.0 (36.0-60.0) | 46.0 (36.0-60.0) |
Daily insulin glargine dose, median (IQR), IU/kg | 0.52 (0.41-0.69) | 0.54 (0.41-0.69) | 0.51 (0.41-0.66) | 0.52 (0.41-0.68) | 0.53 (0.42-0.68) |
HbA1c, %c | 8.74 (1.01) | 8.78 (0.98) | 8.89 (0.97) | 8.80 (0.99) | 8.80 (0.96) |
HbA1c >8.5%, No. (%) | 132 (55.9) | 133 (55.9) | 146 (60.1) | 411 (57.3) | 407 (57.5) |
Fasting serum glucose, mg/dLd | 155.9 (54.3) | 155.8 (55.5) | 163.3 (59.2) | 158.4 (56.4) | 156.3 (56.1) |
eGFR, mL/min/1.73 m2,e | 89.3 (19.9) | 89.5 (18.0) | 89.0 (20.7) | 89.3 (19.6) | 88.8 (18.8) |
eGFR <60 mL/min/1.73 m2, No. (%) | 24 (10.2) | 14 (5.9) | 27 (11.1) | 65 (9.1) | 65 (9.2) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); eGFR, estimated glomerular filtration rate (calculated with use of the serum creatinine–based Chronic Kidney Disease Epidemiology Collaboration equation); HbA1c, glycated hemoglobin A1c.
To meet regulatory requirements, race and ethnicity were recorded in this study and were determined by the participant according to fixed selection categories.
Duration of diabetes was based on the first diagnosis of type 2 diabetes.
Normal value for HbA1c was <6.5%. To convert HbA1c values to mmol/mol, use the following equation: 10.93 × HbA1c − 23.50.
Normal value for fasting serum glucose was 74-106 mg/dL for those younger than 60 years and 82-115 mg/dL for those aged 60-90 years.
Normal value for eGFR was ≥60 mL/min/1.73 m2. Participants with a baseline eGFR less than 30 mL/min/1.73 m2 were excluded from the study.