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ABSTRACT: Aims/introduction
The aim of the present study was to evaluate the long-term efficacy and safety of adding repaglinide in patients with type 2 diabetes mellitus whose blood glucose levels were not sufficiently controlled by treatment with a dipeptidyl peptidase-4 inhibitor, sitagliptin, in addition to diet and exercise therapies.Materials and methods
This was a multicenter, uncontrolled, dose-titration study with a treatment period of 52 weeks. The primary end-point was the change in glycated hemoglobin levels from baseline.Results
The glycated hemoglobin level was 7.43 ± 0.57% (mean ± standard deviation) at baseline, and decreased to 6.93 ± 0.91% at the end of the study. The mean changes in glycated hemoglobin levels at 4 weeks and at the end of the study were -0.44 ± 0.28% and -0.50 ± 0.82%, respectively. The glycated hemoglobin-lowering effect was maintained for 52 weeks. The rate of adverse events was 86.0% (86/100), and there were 352 adverse events. The rate of adverse drug reactions was 21.0% (21/100). Hypoglycemia was reported in 5.0% (5/100) of patients, but there was no incidence of 'major hypoglycemia'.Conclusions
Combination therapy with repaglinide and sitagliptin was considered effective for a long term without clinical safety problems in patients with type 2 diabetes mellitus.
SUBMITTER: Kawamori R
PROVIDER: S-EPMC4773675 | biostudies-literature | 2016 Mar
REPOSITORIES: biostudies-literature
Kawamori Ryuzo R Kaku Kohei K Hanafusa Toshiaki T Ioriya Katsuhisa K Kageyama Shigeru S Hotta Nigishi N
Journal of diabetes investigation 20150719 2
<h4>Aims/introduction</h4>The aim of the present study was to evaluate the long-term efficacy and safety of adding repaglinide in patients with type 2 diabetes mellitus whose blood glucose levels were not sufficiently controlled by treatment with a dipeptidyl peptidase-4 inhibitor, sitagliptin, in addition to diet and exercise therapies.<h4>Materials and methods</h4>This was a multicenter, uncontrolled, dose-titration study with a treatment period of 52 weeks. The primary end-point was the chang ...[more]