Table 2.
Changes in pharmacodynamic characteristics from baseline to day 29 (mITT population)
| Variable | Measurement | Lixisenatide | Sitagliptin | LS mean treatment difference (95% CI); P value |
|---|---|---|---|---|
| (N = 69) | (N = 66) | |||
| Primary endpoint | ||||
| PPG AUC0:00‐4:00h (h·mg/dL) | Baseline | 423.0 ± 179.3 | 398.5 ± 144.5 | – |
| Day 29 (visit 5) | 69.6 ± 186.1 | 291.5 ± 147.2 | – | |
| LS mean change from baseline | −347.3 ± 18.14 | −113.3 ± 18.28 | −234.0 (−285.02, −183.00); P < .0001 | |
| Secondary endpoints | ||||
| Maximum PPG excursion, mg/dL | Baseline | 325.9 ± 56.2 | 316.8 ± 54.5 | – |
| Day 29 (visit 5) | 200.7 ± 60.0 | 272.8 ± 53.7 | – | |
| LS mean change from baseline | −122.4 ± 6.40 | −46.6 ± 6.45 | −75.8 (−93.80, −57.81); P < .0001 | |
| C‐peptide AUC0:00‐4:00h, h ng/mL | Baseline | 7.9 ± 3.3 | 8.5 ± 3.6 | – |
| Day 29 (visit 5) | 3.2 ± 4.5 | 9.3 ± 4.2 | – | |
| LS mean change from baseline | −4.8 ± 0.47 | 0.9 ± 0.48 | −5.8 (−7.10, −4.44); P < .0001 | |
| Glucagon AUC0:00‐4:00h, h pg/mL | Baseline | 58.8 ± 62.8 | 55.4 ± 55.7 | – |
| Day 29 (visit 5) | 17.6 ± 54.2 | 29.8 ± 58.2 | – | |
| LS mean change from baseline | −40.0 ± 6.60 | −26.8 ± 6.64 | −13.2 (−31.69, 5.35); P = .1620 | |
| Fasting 1.5‐AG, µg/mL | Baseline | 4.05 ± 3.76 | 4.08 ± 3.49 | – |
| Day 29 (visit 5) | 5.21 ± 4.45 | 5.76 ± 4.80 | – | |
| LS mean change from baseline | 1.16 ± 0.194 | 1.68 ± 0.196 | −0.52 (−1.067, 0.025); P = .0612 | |
| Fasting glycoalbumin, % | Baseline | 22.54 ± 3.61 | 22.13 ± 3.47 | – |
| Day 29 (visit 5) | 20.46 ± 3.28 | 20.87 ± 3.19 | – | |
| LS mean change from baseline | −2.03 ± 0.210 | −1.31 ± 0.211 | −0.73 (−1.318, −0.139); P = .0158 |
Abbreviations: 1.5‐AG, 1.5‐anhydro‐D‐glucitol; AUC, area under the curve; CI, confidence interval; LS, least squares; PPG, postprandial glucose. Errors are standard deviation for values at baseline and day 29, and standard error for LS mean change from baseline values. To convert glucose mg/dL to mmol/L, multiply by 0.0555; to convert C‐peptide ng/mL to nmol/L, multiply by 0.331; glucagon pg/mL is equivalent to ng/L. ANCOVA model with treatment group (lixisenatide, sitagliptin) and randomization strata of screening sulphonylurea use (yes, no) as fixed effects and the baseline value of the corresponding variable as a covariate. The comparison between groups was achieved through appropriate contrast. If values at more than or equal to 2 time points of 1, 1.5 and 2 hours after the start of standardized breakfast were missing, AUC0 :00‐4:00h was set as missing.