Table 2.
Patients achieving glycated hemoglobin of ≤ 6.5% or < 7.0% at week 24 (full-analysis set, non-completers considered to be failures)
| Patients who achieved HbA1c ≤ 6.5% or < 7.0%a | MET 500 mg bid | LINA/MET 500 mg bid | Odds ratio (95% CI)b | P value | MET 1000 mg bid | LINA/MET 1000 mg bid | Odds ratio (95% CI) | P value |
|---|---|---|---|---|---|---|---|---|
| HbA1c ≤ 6.5%, all patients | 65/284 (22.9) [18.1–28.2] | 112/279 (40.1) [34.3–46.2] | 2.84 (1.87–4.32) | < 0.0001 | 96/271 (35.4) [29.7–41.4] | 139/281 (49.5) [43.5–55.5] | 2.28 (1.54–3.40) | < 0.0001 |
| Baseline HbA1c < 7.5% | 11/17 (64.7) [38.3–85.8] | 15/20 (75.0) [50.9–91.3] | 1.43 (0.27–7.72) | 0.6747 | 15/26 (57.7) [36.9–76.6] | 22/26 (84.6) [65.1–95.6] | 9.98 (2.04–48.72) | 0.0045 |
| Baseline HbA1c ≥ 7.5% to ≤ 9.0% | 43/171 (25.1) [18.8–32.3] | 66/161 (41.0) [33.3–49.0] | 2.54 (1.52–4.27) | 0.0004 | 60/163 (36.8) [29.4–44.7] | 80/151 (53.0) [44.7–61.1] | 2.10 (1.27–3.48) | 0.0040 |
| Baseline HbA1c > 9.0% | 11/96 (11.5) [5.9–19.6] | 31/98 (31.6) [22.6–41.8] | 4.03 (1.77–9.14) | 0.0009 | 21/82 (25.6) [16.6–36.4] | 37/104 (35.6) [26.4–45.6] | 1.81 (0.88–3.70) | 0.1056 |
| Treatment-naïve patients | 64/213 (30.0) [24.0–36.7] | 111/207 (53.6) [46.6–60.6] | 3.17 (2.05–4.91) | < 0.0001 | 91/200 (45.5) [38.5–52.7] | 125/206 (60.7) [53.7–67.4] | 2.10 (1.36–3.23) | 0.0007 |
| HbA1c < 7.0%, all patients | 98/284 (34.5) [29.0–40.4] | 142/276 (51.4) [45.4–57.5] | 2.45 (1.66–3.60) | < 0.0001 | 131/266 (49.2) [43.1–55.4] | 182/278 (65.5) [59.6–71.0] | 2.47 (1.67–3.65) | < 0.0001 |
| Baseline HbA1c < 7.5% | 15/17 (88.2) [63.6–98.5] | 15/17 (88.2) [63.6–98.5] | 0.85 (0.09–7.78) | 0.8871 | 16/21 (76.2) [52.8–91.8] | 22/23 (95.7) [78.1–99.9] | 9.50 (0.93–96.7) | 0.0572 |
| Baseline HbA1c ≥ 7.5% to ≤ 9.0% | 65/171 (38.0) [30.7–45.7] | 85/161 (52.8) [44.8–60.7] | 2.17 (1.33–3.52) | 0.0018 | 86/163 (52.8) [44.8–60.6] | 107/151 (70.9) [62.9–78.0] | 2.40 (1.44–4.00) | 0.0008 |
| Baseline HbA1c > 9.0% | 18/96 (18.8) [11.5–28.0] | 42/98 (42.9) [32.9–53.3] | 3.50 (1.75–7.01) | 0.0004 | 29/82 (35.4) [25.1–46.7] | 53/104 (51.0) [41.0–60.9] | 2.20 (1.15–4.20) | 0.0174 |
| Treatment-naïve patients | 94/213 (44.1) [37.4–51.1] | 131/204 (64.2) [57.2–70.8] | 2.60 (1.70–3.98) | < 0.0001 | 118/195 (60.5) [53.3–67.4] | 152/203 (74.9) [68.3–80.7] | 2.15 (1.36–3.40) | 0.0011 |
The full-analysis set included all patients (N = 1116) who were randomized and treated with at least one dose of study drug, had a baseline HbA1c measurement and had at least one HbA1c measurement during treatment
CI Confidence interval
aValues for each treatment arm are presented as the ratio of patients n/N, where n = number of patients with HbA1c below the threshold (6.5 or 7.0%), and N = number of analyzed patients within treatment group, with the percentage given in parenthesis and the 95% CI given in square brackets
bLogistic regression includes study, treatment and continuous baseline HbA1c (exact Clopper–Pearson CI)