Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicenter, randomized, double-blind, parallel-group, comparative study.

Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicenter, randomized, double-blind, parallel-group, comparative study.
Diabetes Obes Metab. 2015 Aug 17;
Authors: Kaku K, Katou M, Igeta M, Ohira T, Sano H
Abstract
A phase 4, multicenter, randomized, double-blind, parallel-group, comparative study was conducted in Japanese T2DM subjects who had inadequate glycemic control despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycosylated hemoglobin (HbA1c) of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (Week 16). Both pioglitazone 15 mg and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs. 0.00% (the least square mean using ANCOVA model); p<0.0001, respectively]. The overall incidences of treatment-emergent adverse events were comparable among the treatment groups. Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese T2DM and is considered to be useful in clinical settings.
PMID: 26277887 [PubMed - as supplied by publisher]

Source: Diabetes Metab - August 17, 2015 Category: Endocrinology Authors: Kaku K, Katou M, Igeta M, Ohira T, Sano H Tags: Diabetes Obes Metab Source Type: research