Dataset Information

Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.

ABSTRACT:

Aims

To evaluate the efficacy and safety of evogliptin, a newly developed dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise.

Materials and methods

In this randomized, double-blind, placebo-controlled, parallel-group, multicentre, phase III study, 160 patients with T2D were assigned to either evogliptin 5 mg or placebo for 24 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to week 24.

Results

The mean baseline HbA1c levels were similar in the evogliptin and the placebo groups (7.20% ± 0.56% vs 7.20% ± 0.63%, respectively). At week 24, evogliptin significantly reduced HbA1c levels from baseline compared with placebo (-0.23% vs 0.05%, respectively, P < .0001). Additionally, the proportion of patients achieving HbA1c <6.5% was significantly higher in the evogliptin group than in the placebo group (33.3% vs 15.2%; P = .008). The overall incidence of adverse events, including hypoglycaemia, was similar in the 2 groups.

Conclusions

In this 24-week study, once-daily evogliptin monotherapy significantly improved glycaemic control and was well tolerated in patients with T2D.

SUBMITTER: Park J

PROVIDER: S-EPMC5697645 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.

Park Juri J Park Sung Woo SW Yoon Kun Ho KH Kim Sung Rae SR Ahn Kyu Jeung KJ Lee Jae Hyuk JH Mok Ji Oh JO Chung Choon Hee CH Han Kyung Ah KA Koh Gwan Pyo GP Kang Jun Goo JG Lee Chang Beom CB Kim Seong Hwan SH Kwon Na Young NY Kim Doo Man DM

Diabetes, obesity & metabolism 20170707 12

<h4>Aims</h4>To evaluate the efficacy and safety of evogliptin, a newly developed dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise.<h4>Materials and methods</h4>In this randomized, double-blind, placebo-controlled, parallel-group, multicentre, phase III study, 160 patients with T2D were assigned to either evogliptin 5 mg or placebo for 24 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from basel ...[more]

PMID: 28448688

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Dataset Information

Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.

Aims

Materials and methods

Results

Conclusions

Publications

Efficacy and safety of evogliptin monotherapy in patients with type 2 diabetes and moderately elevated glycated haemoglobin levels after diet and exercise.

Similar Datasets

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