title: Effect of Acarbose on Glycemic Variability in Patients with Poorly Controlled Type 2 Diabetes Mellitus Receiving Stable Background Therapy: A Placebo-Controlled Trial.
abstract: OBJECTIVE
  To evaluate the effect of acarbose on glycemic control and glycemic variability, using a continuous glucose-monitoring system, in patients with type 2 diabetes mellitus who were not well controlled on metformin and vildagliptin therapy.
  
  
  METHODS
  Multicenter, randomized, double-blind, placebo-controlled study.
  
  
  METHODS
  Clinical research units at three hospitals in Italy.
  
  
  METHODS
  Fifty-three patients with type 2 diabetes who were taking stable dosages of metformin 850 mg 3 times/day and vildagliptin 50 mg twice/day for at least 3 months and who were not adequately controlled with these therapies.
  
  
  METHODS
  Patients were randomized to either placebo or acarbose 100 mg 3 times/day to be added to their metformin-vildagliptin regimen.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.|Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy.|Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.affiliation: Metabolic Unit, S. Antonio Abate Hospital, Gallarate, Varese, Italy.
authors.forename: Ivano
authors.initials: I
authors.lastname: Franzetti
authors.affiliation: Ospedale Pesenti Fenaroli, Alzano Lombardo, Bergamo, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Querci
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.|Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy.
authors.forename: Angela
authors.initials: A
authors.lastname: D'Angelo
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.|PhD School in Experimental Medicine, University of Pavia, Pavia, Italy.
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
mesh_terms: D020909:Acarbose / Q000009:adverse effects / Q000627:therapeutic use*; D000218:Adamantane / Q000031:analogs & derivatives / Q000627:therapeutic use; D001786:Blood Glucose / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D065089:Glycoside Hydrolase Inhibitors / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000627:therapeutic use; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D009570:Nitriles / Q000627:therapeutic use; D011759:Pyrrolidines / Q000627:therapeutic use; D000077597:Vildagliptin
chemical_list: D001786:Blood Glucose; D065089:Glycoside Hydrolase Inhibitors; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D008687:Metformin; D000077597:Vildagliptin; D000218:Adamantane; D020909:Acarbose
keywords: acarbose; continuous glucose-monitoring system; glycemic variability; vildagliptin