Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with
type 2 diabetes: A randomized, double-blind, placebo-controlled trial with an
open-label, long-term extension study.
Author(s): Seino Y(1), Hiroi S(2), Hirayama M(2), Kaku K(3).
Affiliation(s): Author information:
(1)Kansai Electric Power Hospital Osaka Japan. (2)Takeda Pharmaceutical Company
Osaka Japan. (3)Kawasaki Medical School Okayama Japan.
Publication date & source: 2012, J Diabetes Investig. , 3(6):517-25
AIMS/INTRODUCTION: To evaluate the efficacy and safety of alogliptin added to
treatment with glimepiride.
MATERIALS AND METHODS: This multicenter, randomized, double-blind,
parallel-group, 24-week (12-week observation and 12-week treatment) study
compared alogliptin 12.5 or 25 mg in combination with glimepiride (1-4 mg/day) vs
placebo added to glimepiride monotherapy in Japanese patients with type 2
diabetes who had poor glycemic control despite treatment with diet and exercise
plus a sulfonylurea. The primary end-point was a change in glycated hemoglobin
(HbA1c) from baseline. A 40-week open-label extension study evaluated the
long-term safety and efficacy of the combination.
RESULTS: Alogliptin 12.5 or 25 mg in combination with glimepiride significantly
decreased HbA1c compared with glimepiride monotherapy after 12 weeks' treatment
(-0.59, -0.65 and 0.35%, respectively; P < 0.0001 for both combination groups vs
glimepiride monotherapy). Alogliptin 12.5 and 25 mg combination therapy was also
associated with significantly higher responder rates (HbA1c <6.9%: 9.6% and 7.7%,
HbA1c <7.4%: 29.8% and 34.6%) compared with glimepiride monotherapy (HbA1c <6.9%:
0%, HbA1c <7.4%: 3.9%). The incidence of adverse events was comparable between
glimepiride monotherapy and alogliptin combination treatment, with most reported
adverse events being mild in severity. In the extension study, the incidence of
adverse events was comparable between the combination groups, with the majority
of adverse events being mild.
CONCLUSIONS: Once-daily alogliptin was effective and generally well tolerated
when given as add-on therapy to glimepiride in Japanese patients with type 2
diabetes who had inadequate glycemic control on sulfonylurea plus lifestyle
measures. Clinical benefits were maintained for 52 weeks. This trial was
registered with ClinicalTrials.gov (double-blind study no. NCT01318083; long-term
study no. NCT01318135).
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