RESUMEN
BACKGROUND: Patients with type 2 diabetes mellitus often take multiple anti-diabetic drugs for a long period. Fixed dose combination (FDC) therapy is expected to improve drug adherence for patients with diabetes. The effect of switching from a loose dose combination (LDC) regimen to an FDC regimen at equivalent dosage on glycemic control has not been evaluated fully. Therefore, we investigated the effect of switching from LDC to FDC at equivalent dosage for 6 months on glycemic control in Japanese patients with type 2 diabetes. METHODS: Thirty-eight Japanese patients with type 2 diabetes who were taking anti-diabetic drugs including pioglitazone + metformin, pioglitazone + alogliptin, or pioglitazone + glimepiride were enrolled. These drugs were switched to an FDC of Metact®, Liobel® or Sonias®, respectively, at equivalent dosage. Other anti-diabetic drugs and units of insulin were not changed during the study if possible. HbA1c and body weight were measured 0, 2, 4 and 6 months after switching from an LDC to FDC. We also conducted a questionnaire survey 2 months after the start of the FDC regimen. RESULTS: HbA1c levels at 2, 4, and 6 months were not significantly changed compared with prior to switching from an LDC to FDC regimen. Moreover, 74.2% of patients considered decreasing the number of drugs to be "very good" or "good". CONCLUSION: HbA1c levels did not differ between patients receiving LDC and FDC therapy at equivalent dosage in this study.
RESUMEN
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.
