Table 1.
Baseline demographics and patient characteristics
| Parameter | Tirzepatide 5 mg n = 121 | Tirzepatide 10 mg n = 121 | Tirzepatide 15 mg n = 121 | Placebon = 115 |
|---|---|---|---|---|
| Age, years | 54.1 ± 11.9 | 55.8 ± 10.4 | 52.9 ± 12.3 | 53.6 ± 12.8 |
| Female, n (%) | 65 (53.7) | 49 (40.5) | 58 (47.9) | 59 (51.3) |
| Duration of diabetes, years | 4.6 ± 5.08 | 4.9 ± 5.61 | 4.8 ± 4.99 | 4.5 ± 5.87 |
| HbA1c, % | 8.0 ± 0.84 | 7.9 ± 0.78 | 7.9 ± 1.02 | 8.1 ± 0.80 |
| Fasting serum glucose, mg/dL | 153.7 ± 37.28 | 152.6 ± 41.72 | 153.3 ± 40.40 | 154.8 ± 40.26 |
| Weight, kg | 87.0 ± 21.15 | 86.2 ± 19.50 | 85.4 ± 18.51 | 84.8 ± 20.01 |
| BMI, kg/m2 | 32.2 ± 6.98 | 32.2 ± 7.65 | 31.5 ± 5.48 | 31.7 ± 6.07 |
| Prior use of OAM, n (%) | 55 (45.5) | 53 (43.8) | 56 (46.3) | 55 (47.8) |
| Fasting insulin, pmol/L | 96.2 ± 6.09 | 90.7 ± 5.82 | 95.2 ± 6.19 | 84.8 ± 5.64 |
| HOMA2-B (computed with c-peptide) | 52.9 ± 2.67 | 51.8 ± 2.63 | 49.0 ± 2.54 | 49.4 ± 2.60 |
| HOMA2-IR (computed with insulin) | 2.0 ± 0.11 | 1.8 ± 0.10 | 2.0 ± 0.12 | 1.8 ± 0.10 |
| Proinsulin/C-peptide ratio | 11.1 ± 0.66 | 13.2 ± 0.80 | 12.8 ± 0.81 | 12.5 ± 0.84 |
| Fasting proinsulin, pmol/L | 8.2 ± 0.62 | 9.3 ± 0.72 | 8.9 ± 0.69 | 9.0 ± 0.71 |
| Fasting C-peptide, nmol/L | 0.8 ± 0.03 | 0.7 ± 0.03 | 0.7 ± 0.03 | 0.7 ± 0.03 |
| Adiponectin, mg/mL | 3.7 ± 0.21 | 3.8 ± 0.22 | 3.9 ± 0.23 | 3.8 ± 0.22 |
| IGFBP-2, ng/mL | 189.8 ± 10.1 | 195.3 ± 10.6 | 194.4 ± 10.5 | 207.5 ± 11.5 |
Data are mean ± SD or n (%) at baseline all randomized population (patient demographics) and estimate means (SE) from mITT population using log transformation then convert back to original scale (beta-cell function and insulin sensitivity parameters).
Abbreviations: HbA1c, glycosylated hemoglobin A1c; HOMA2-B, homeostatic model assessment for beta-cell function; HOMA2-IR, homeostatic model assessment for insulin resistance; IGFBP-2, insulin-like growth factor binding protein 2; mITT, modified intent-to-treat; OAM, oral antihyperglycemic medication.