Comparison of efficacy and safety of taking miglitol dissolved in water during a meal and taking a miglitol tablet just before a meal in patients with type 2 diabetes

ABSTRACT

Objective: We compared the efficacy and safety of taking miglitol dissolved in water during a meal and taking a miglitol tablet just before a meal. Primary efficacy parameter is the area under the curve (AUC) for postprandial plasma glucose.

Methods: Miglitol was administered according to three different intake schedules in each subject: intake schedule A, no miglitol; intake schedule B, administration of miglitol (50 mg) just before breakfast; intake schedule C, dissolving miglitol (50 mg) in water and taking it just before (1/3), during (1/3), and just after breakfast (1/3). Blood samples were collected at 0, 30, 60, 120, and 180 min after breakfast.

Results: The AUCs for plasma glucose, insulin, and total glucose-dependent insulinotropic polypeptide (GIP) were significantly lower for intake schedules B and C, compared with those for intake schedule A. The AUC for total glucagon like peptide-1(GLP-1) was higher for intake schedule C than for intake schedule A. The coefficient of variation (CV) of plasma glucose was significantly lower for intake schedule C than for intake schedules A and B.

Conclusion: Taking miglitol dissolved in water was equivalent to taking a miglitol tablet. The CV of plasma glucose was significantly lower for the dissolved-dose regimen.

KEYWORDS:

• Miglitol
• liquid formulation
• tablet formulation
• type 2 diabetes
• postprandial glucose

Declaration of interest

This work was supported in part by Grants-in-Aid for Scientific Research (B) 21390282 and (B) 24390235 from the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan, and a Medical Award from the Japan Medical Association. Y Terauchi has received honoraria for lectures from MSD K.K.; Ono Pharmaceutical Co., Ltd.; Nippon Boehringer Ingelheim Co., Ltd.; Novartis Pharma K.K.; Takeda Pharmaceutical Co., Ltd.; Mitsubishi Tanabe Pharma Corp.; Daiichi Sankyo Co., Ltd.; Sanwa Kagaku Kenkyusho Co., Ltd.; Kowa Pharmaceutical Co., Ltd.; Novo Nordisk Pharma Ltd.; Eli Lilly Japan K.K.; Sanofi K.K.; Shionogi & Co., Ltd.; Bayer Yakuhin, Ltd.; and AstraZeneca K.K. and has obtained research support from MSD K.K.; Ono Pharmaceutical Co., Ltd.; Nippon Boehringer Ingelheim Co., Ltd.; Novartis Pharma K.K.; Takeda Pharmaceutical Co., Ltd.; Mitsubishi Tanabe Pharma Corp.; Daiichi Sankyo Co., Ltd.; Sanwa Kagaku Kenkyusho Co., Ltd.; Novo Nordisk Pharma Ltd.; Eli Lilly Japan K.K.; Sanofi K.K.; Dainippon Sumitomo Pharma Co., Ltd.; Shionogi & Co., Ltd.; Bayer Yakuhin, Ltd.; Astellas Pharma, Inc.; Pfizer Japan, Inc.; and AstraZeneca K.K. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed