Table 2.
Change from baseline to week 104 for secondary efficacy parameters [intention-to-treat (ITT) Population]
| Liraglutide 1.2 mg | Liraglutide 1.8 mg | Glimepiride 8 mg | |||
|---|---|---|---|---|---|
| Endpoint | Δ | ETD [95% CI] and p-value versus glimepiride | Δ | ETD [95% CI] and p-value versus glimepiride | Δ |
| HbA1c, % | −0.6 | −0.31 [−0.54; −0.08], 0.0076 | −0.9 | −0.60 [−0.83; −0.38], <0.0001 | −0.3 |
| HbA1c <7% (<53 mmol/mol), % participants* | 36.9 | 1.98 [1.30; 3.00], 0.0015 | 44.4 | 2.81 [1.85; 4.26], <0.0001 | 23.2 |
| HbA1c ≤6.5%, (<48 mmol/mol) % participants* | 25.0 | 1.84 [1.15; 2.95], 0.0113 | 29.9 | 2.39 [1.50; 3.80], 0.0002 | 15.4 |
| FPG, mmol/l | −0.52 | −0.63 [−1.17; −0.09], 0.0217 | −0.88 | −0.99 [−1.53; −0.45], 0.0003 | 0.11 |
| PPG, mmol/l | −1.52 | −0.14 [−0.66; 0.39], 0.6060 | −2.06 | −0.68 [−1.21; −0.16], 0.0105 | −1.38 |
| Body weight, kg | −1.89 | −2.84 [−3.63; −2.06], <0.0001 | −2.70 | −3.65 [−4.44; −2.86], <0.0001 | 0.95 |
| Waist circumference, cm | −3.48 | −3.08 [−4.72; −1.44], 0.0002 | −3.73 | −3.33 [−4.98; −1.69], <0.0001 | −0.40 |
| HOMA-B, % | 20.63 | 3.72 [−21.91; 29.34], 0.7757 | 24.66 | 7.74 [−18.10; 33.58], 0.5565 | 16.91 |
| HOMA-IR, % | −0.38 | −1.50 [−2.92; −0.08], 0.0388 | −0.86 | −1.99 [−3.42; −0.55], 0.0067 | 1.13 |
| Fasting insulin, pmol/l | −2.03 | −17.91 [−41.65; 5.83], 0.1390 | −1.86 | −17.74 [−41.71; 6.24], 0.1468 | 15.88 |
| Fasting C-peptide, nmol/l | 10.05 | −0.51 [−9.47; 8.46], 0.9117 | 14.36 | 3.80 [−5.27; 12.87], 0.4104 | 10.56 |
| Pro-insulin/insulin ratio | 0.05 | −0.05 [−0.12; 0.02], 0.1403 | 0.01 | −0.10 [−0.17; −0.03], 0.0045 | 0.10 |
| Fasting glucagon, pg/ml | −11.85 | −6.86 [−13.52; −0.21], 0.0433 | −9.92 | −4.93 [−11.69; 1.84], 0.1535 | −4.99 |
| SBP, mmHg | −1.35 | −0.86 [−3.18; 1.46], 0.4657 | −2.37 | −1.88 [−4.21; 0.45], 0.1135 | −0.49 |
| DBP, mmHg | −0.58 | −0.14 [−1.50; 1.23], 0.8429 | −0.81 | −0.37 [−1.74; 1.00], 0.5965 | −0.44 |
| Pulse, bpm | 2.04 | 1.36 [−0.17; 2.90], 0.0821 | 0.92 | 0.24 [−1.30; 1.78], 0.7589 | 0.67 |
Δ = Change from baseline to the end of the trial (week 104), ITT (last observation carried forward). Data are least square means, unless otherwise noted. p-values from statistically significant comparisons are in bold text. bpm, beats per minute; CI, confidence interval; DBP, diastolic blood pressure; ETD, estimated treatment difference (liraglutide–glimepiride); FPG, fasting plasma glucose; HbA1c, glycosylated haemoglobin; HOMA-B, homeostasis model assessment of β-cell function; HOMA-IR, homeostasis model assessment of insulin resistance; PPG, postprandial plasma glucose; SBP, systolic blood pressure.
Percentage reaching target from a logistic regression model and odds ratio presented rather than treatment difference.