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Randomized Controlled Trial
. 2015 Feb;17(2):152-60.
doi: 10.1111/dom.12403.

A randomized, double-blind, placebo-controlled study on long-term efficacy and safety of ipragliflozin treatment in patients with type 2 diabetes mellitus and renal impairment: results of the long-term ASP1941 safety evaluation in patients with type 2 diabetes with renal impairment (LANTERN) study

A Kashiwagi  1 , H Takahashi, H Ishikawa, S Yoshida, K Kazuta, A Utsuno, E Ueyama
Affiliations
Randomized Controlled Trial

A randomized, double-blind, placebo-controlled study on long-term efficacy and safety of ipragliflozin treatment in patients with type 2 diabetes mellitus and renal impairment: results of the long-term ASP1941 safety evaluation in patients with type 2 diabetes with renal impairment (LANTERN) study

A Kashiwagi et al. Diabetes Obes Metab. 2015 Feb.

Abstract

Aims: To assess the effects of renal impairment (RI) on the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus (T2DM).

Methods: A cohort of Japanese patients with T2DM and mild to moderate RI and poor glycaemic control, despite diet/exercise therapy alone or diet/exercise therapy in combination with an oral hypoglycaemic agent (an α-glucosidase inhibitor, a sulfonylurea, or pioglitazone), were randomized in a double-blind manner to 50 mg ipragliflozin or placebo once daily for 24 weeks. The patients continued open-label ipragliflozin for a 28-week extension period (total treatment duration: 52 weeks).

Results: Ipragliflozin significantly decreased glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) levels and body weight from baseline to week 24 (last observation carried forward) compared with placebo in all patients with RI. The decreases in HbA1c and FPG levels were statistically significant in patients with mild RI, but not in patients with moderate RI. Ipragliflozin significantly reduced body weight in both RI groups. The improvements in glycaemic control were maintained in the 28-week extension period. Ipragliflozin was associated with no clinically significant safety concerns, and its safety profiles were not influenced by the severity of RI.

Conclusions: Ipragliflozin significantly improved glycaemic control and body weight in patients with T2DM with mild RI, but did not improve glycaemic control in patients with moderate RI. Ipragliflozin is a valid treatment option for patients with mild RI but not those with moderate RI.

Keywords: SGLT2 inhibitor.

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Figures

Figure 1
Figure 1
Patient disposition. Data for treatment period 2 are not shown for patients allocated to placebo in treatment period 1. RI, renal impairment.
Figure 2
Figure 2
Change in glycated haemoglobin (HbA1c) from baseline to endpoint in all patients according to treatment group. CI, confidence interval; NGSP, National Glycohemoglobin Standardization Program.
Figure 3
Figure 3
Change in glycated haemoglobin (HbA1c) from baseline to endpoint in patients with mild or moderate renal impairment (RI) according to treatment group. The changes from baseline to week 24 are also shown with the LOCF to impute missing data. Data are shown as the mean ± standard deviation. NGSP, National Glycohemoglobin Standardization Program.
Figure 4
Figure 4
Change in body weight from baseline to endpoint in patients with mild or moderate renal impairment (RI) according to treatment group. The changes from baseline to week 24 are also shown with the LOCF to impute missing data. Data are shown as the mean ± standard deviation.
See this image and copyright information in PMC

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