Table 3.
Glycemic Fluctuation and Variability in Patients with Type 2 Diabetes Treated for 52 Weeks in the DUAL I Extension Continuous Glucose Monitoring Sub-Study
| CGM parameter | IDegLira (n = 131) | IDeg (n = 64) | ETD [95% CI]: IDegLira vs. IDeg | Lira (n = 65) | ETD [95% CI]: IDegLira vs. Lira |
|---|---|---|---|---|---|
| Mean IG (mmol/L) | |||||
| Mean at baseline | 10.2 (2.2) | 10.2 (2.1) | 10.0 (2.5) | ||
| Mean Δ, w52 | −3.5 (1.9) | −3.6 (1.9) | 0.0 [−0.5 to 0.5] (P = 0.9655) | −2.5 (2.5) | −1.0 [−1.5 to −0.5] (P < 0.0001) |
| IG fluctuation (adjusted integrated absolute distance from the mean profile, i.e., flatness of IG profile, mmol/L) | |||||
| Geometric mean at baseline | 1.5 | 1.6 | 1.5 | ||
| Geometric mean at w52 | 1.0 | 1.3 | Ratio: 0.8 [0.7 to 0.9] (P = 0.0018) | 1.1 | Ratio: 1.0 [0.8 to 1.1] (P = 0.6681) |
| Postprandial IG increment across all meals (90 min, mmol/L) | |||||
| Mean at baseline | 1.4 (1.3) | 1.4 (1.8) | 1.5 (1.2) | ||
| Mean Δ, w52 | −0.5 (1.2) | 0.2 (1.8) | −0.5 [−0.9 to −0.1] (P = 0.0288) | −0.2 (1.4) | −0.2 [−0.6 to 0.2] (P = 0.3039) |
| Day-to-day IG variability (SD of daily [24 h] mean, mmol/L) | |||||
| Mean at baseline (SE) | 0.8 (0.1) | 1.0 (0.1) | 0.8 (0.1) | ||
| Mean at w52 (SE) | 0.6 (0.0) | 0.6 (0.1) | −0.1 [−0.2 to 0.1] (P = 0.4197) | 0.5 (0.1) | 0.1 [−0.0 to 0.3] (P = 0.1056) |
| Day-to-day variability of fasting IG, 20 min before breakfast (SD of daily fasting IG, mmol/L) | |||||
| Geometric mean at baseline (CV) | 0.8 (115.4) | 0.7 (130.4) | 0.8 (127.5) | ||
| Geometric mean at w52 (CV) | 0.6 (106.7) | 0.5 (139.9) | Ratio: 0.9 [0.6 to 1.3] (P = 0.4811) | 0.5 (121.1) | Ratio: 0.8 [0.5 to 1.2] (P = 0.2462) |
Values are mean (SD) unless otherwise stated. CGM parameters are analyzed based on observed data using an ANCOVA method with treatment, region, baseline HbA1c stratum (≤8.3% [≤67 mmol/mol], >8.3% [>67 mmol/mol]), and previous OAD treatment as fixed effects. Baseline values of parameters were included as covariates for mean IG and postprandial IG increment. Fluctuation is log-transformed before analysis.
ANCOVA, analysis of covariance; CV, coefficient of variation; ETD, estimated treatment difference; IG, interstitial glucose; Lira, liraglutide; SE, standard error; w, week.