DESIGN: Multicenter, randomized, double-blind, placebo-controlled study.
SETTING: Clinical research units at three hospitals in Italy.
PATIENTS: Glycemic excursions were assessed by using a continuous
glucose-monitoring system for 1 week.
Glycemic control was estimated as the mean
blood glucose (MBG) level, the area under the
glucose concentration-time curve for a
glucose level above 70 mg/dl (AUC above 70) or 180 mg/dl (AUC above 180), and the percentage of time that the
glucose level was above 70 mg/dl (T above 70) or 180 mg/dl (T above 180). Intraday glycemic variability was assessed by the standard deviation of the
blood glucose level, the mean amplitude of glycemic excursions (MAGE), the M value, and continuous overlapping net glycemic action. Day-to-day glycemic variability was assessed as the mean of daily difference (MODD). The MBG level was ~20 mg/dl lower in the
acarbose group than in the placebo group (p<0.05), particularly during the postprandial period. The AUC above 70 did not significantly differ between the two groups, whereas the AUC above 180 was ~40% lower in the
acarbose group than in the placebo group during the daytime (p<0.01). The T above 180 was significantly higher in the placebo group than in the
acarbose group (31% vs 8%, p<0.01. Moreover, the standard deviation and MAGE values were significantly lower in the
acarbose group. The MODD value was not significantly changed in either group, and no significant differences were recorded between groups. All adverse events were mild in both groups, with only a significantly greater frequency of
flatulence noted in the
acarbose group (5% with
acarbose vs 0.5% with placebo, p<0.05).
CONCLUSION: The addition of
acarbose to
metformin and
vildagliptin background
therapy in patients with inadequately controlled
type 2 diabetes decreased intraday glycemic variability, especially postprandial variability, but it was not associated with a significant change in interday glycemic variability.