Comparison of the antidiabetic effects of linagliptin among groups with a normal renal function and a mild or severe renal impairment - retrospective observation study of Japanese patients with type 2 diabetes mellitus.

Objective: The clinical course > 6 months after the initiation of linagliptin in patients with type 2 diabetes was compared among the groups divided by their renal function.

Methods: Two hundred and sixteen Japanese patients with type 2 diabetes treated with 5 mg once daily linagliptin were studied as the treated set. One hundred and forty-five subjects whose medications were not changed during the observation period were investigated as the full analysis set to assess the effectiveness. The subjects were divided into three groups based on an eGFR: eGFR ≥ 60, 59 - 45 and < 45 ml/min/1.73 m(2). The parameters were analyzed separately in the patients receiving monotherapy and additional therapy of linagliptin.

Results: The HbA1c (NGSP) levels significantly improved in both the patients receiving monotherapy and additional therapy. The changes in the HbA1c levels at 6 months were not significantly different between the groups with an eGFR ≥ 60, 59 - 45 and < 45 ml/min/1.73 m(2) receiving monotherapy (-1.0, -0.8 and -0.8%, respectively). Similarly, those were not significantly different between the different groups receiving additional therapy (-0.6, -0.5 and -0.7%, respectively).

Conclusions: Linagliptin is considered to be effective for patients with type 2 diabetes and renal impairment in the present analysis performed at our institution.