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Abstract
Objective: We investigated the effect of addition of alogliptin, while continuing the α-glucosidase inhibitor (αGI) administration at the same or reduced dose, or discontinuing the drug, on the glycemic control in type 2 diabetic patients showing inadequate response to αGI treatment.
Research design and methods: A prospective, randomized, controlled, multicenter interventional study trial. Subjects were randomly assigned to treatment with alogliptin alone (Intake 0 group), or alogliptin in addition to an αGI administered once-/twice-/thrice-daily (Intake 1, 2 and 3 groups).
Main outcome measures: Changes in glycemic control were measured.
Results: The HbA1c and glycoalbumin levels at 1 and 3 months were significantly lower than the values at the baseline in the Intake 1, 2 and 3 groups, but not the Intake 0 group. The body weight at 3 months was significantly lower than that at the baseline in the Intake 3 group. There were no significant differences in the degree of satisfaction or participating volition recorded, before and after the start of the study treatments.
Conclusions: Addition of alogliptin to once-/twice-daily administration of an αGI may be effective for obtaining improved glycemic control, without lowering the treatment satisfaction level, in type 2 diabetic patients.
Acknowledgments
This work was supported in part by Grants-in-Aid for Scientific Research (B) 19390251, (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, and the Suzuken Memorial foundation. K Masuda, K Aoki and Y Terauchi designed research; all authors conducted research; K Masuda and K Aoki analyzed data; K Masuda, K Aoki and Y Terauchi wrote the paper. Y. Terauchi had primary responsibility for final content. All authors read and approved the final manuscript. Trial Registration: UMIN (http://www.umin.ac.jp/english/) 000004259.