The combination of a dipeptidyl peptidase-4 (DPP-4) inhibitor and a
long-acting insulin analogue is widely used in clinical practice. However, some patients fail to achieve lower
postprandial hyperglycemia.
Mitiglinide, a short-acting insulinotropic
sulfonylurea receptor ligand, is effective for
postprandial hyperglycemia. Recently, it has been reported that the combination
therapy of
mitiglinide with a
DPP-4 inhibitor could improve
glycemic control. However, the efficacy of those under
long-acting insulin analogue
therapy remains to be investigated. Thus, we conducted a prospective single-center study of eight Japanese patients with
type 2 diabetes mellitus receiving
mitiglinide added to the combination
therapy of
sitagliptin and
insulin glargine, and evaluated its efficacy and safety by continuous
glucose monitoring (CGM). Participants' (four men and four women) mean age was 70.3 ± 10.6 years. Their mean body mass index, HbA1c level, and urinary
C-peptide level were 22.0 ± 2.8 kg/m(2), 9.2 ± 1.2%, and 50.0 ± 31.4 μg/day, respectively. CGM showed that as compared with the combination of only
sitagliptin and
insulin glargine,
mitiglinide in combination with
sitagliptin and
insulin glargine significantly reduced glycemic fluctuation indices, total area for the range of 24-h glycemic fluctuations (p = 0.04), mean amplitude of glycemic excursions (p = 0.03), and the proportion of time in
hyperglycemia (p = 0.02) without significant difference in the proportion of time in
hypoglycemia (p = 0.18). Hence, we have demonstrated the efficacy and safety of the add-on treatment with
mitiglinide in type 2 diabetic patients, receiving the combination
therapy of
sitagliptin and
insulin glargine.