CLINICAL RESEARCH e-ISSN 1643-3750 © Med Sci Monit, 2015; 21: 2678-2684 DOI: 10.12659/MSM.894026
Effect of Linagliptin on Glycemic Control in Chinese Patients with Newly-Diagnosed, DrugNaïve Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Received: 2015.03.05 Accepted: 2015.05.21 Published: 2015.09.09
Authors’ Contribution: Study Design A Data Collection B Analysis C Statistical Data Interpretation D Manuscript Preparation E Literature Search F Funds Collection G
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Corresponding Authors: Source of support:
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Wenjun Wu Ying Li Xiong Chen Dini Lin Songying Xiang Feixia Shen Xuemei Gu
1 Department of Endocrinology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, P.R. China 2 Clinical Teaching Affairs Office, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, P.R. China 3 Department of Gynecology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, P.R. China
Feixia Shen, e-mail: [email protected], Xuemei Gu, e-mal: [email protected] This work was supported by the National Science Foundation for Young Scholars of China (Grant No.81000356)
This study aimed to evaluate the efficacy and safety of linagliptin (a novel dipeptidyl peptidase (DPP)-4 inhibitor) on glucose metabolism and b-cell function in Chinese patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus (T2DM). Newly-diagnosed and drug-naïve T2DM patients were enrolled. After 4-week lifestyle modulation and 2-week placebo run-in, 57 patients were randomized to double-blind treatment with linagliptin (n=34) or placebo (n=23). The primary endpoint was the change from baseline in glycosylated hemoglobin A1c (HbA1c) after 24 weeks. Fasting plasma glucose (FPG), 2-h postprandial plasma glucose (2h-PPG), fasting insulin, proinsulin-to-insulin ratio, homeostasis model assessment of insulin resistance (HOMA-IR), and homeostasis model assessment of b-cell function (HOMA-b) were also evaluated. Baseline characteristics were similar between the 2 groups. Compared with placebo, linagliptin therapy resulted in a significant decrease in HbA1C (–1.2±0.7% vs. –0.4±0.4%, P
Effect of Linagliptin on Glycemic Control in Chinese Patients with Newly-Diagnosed, DrugNaïve Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Received: 2015.03.05 Accepted: 2015.05.21 Published: 2015.09.09
Authors’ Contribution: Study Design A Data Collection B Analysis C Statistical Data Interpretation D Manuscript Preparation E Literature Search F Funds Collection G
AB 1 BC 2 BC 1 CD 1 CD 3 ABCDEFG 1 DE 1
Corresponding Authors: Source of support:
Background:
Material/Methods:
Results:
Conclusions:
MeSH Keywords:
Full-text PDF:
Wenjun Wu Ying Li Xiong Chen Dini Lin Songying Xiang Feixia Shen Xuemei Gu
1 Department of Endocrinology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, P.R. China 2 Clinical Teaching Affairs Office, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, P.R. China 3 Department of Gynecology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, P.R. China
Feixia Shen, e-mail: [email protected], Xuemei Gu, e-mal: [email protected] This work was supported by the National Science Foundation for Young Scholars of China (Grant No.81000356)
This study aimed to evaluate the efficacy and safety of linagliptin (a novel dipeptidyl peptidase (DPP)-4 inhibitor) on glucose metabolism and b-cell function in Chinese patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus (T2DM). Newly-diagnosed and drug-naïve T2DM patients were enrolled. After 4-week lifestyle modulation and 2-week placebo run-in, 57 patients were randomized to double-blind treatment with linagliptin (n=34) or placebo (n=23). The primary endpoint was the change from baseline in glycosylated hemoglobin A1c (HbA1c) after 24 weeks. Fasting plasma glucose (FPG), 2-h postprandial plasma glucose (2h-PPG), fasting insulin, proinsulin-to-insulin ratio, homeostasis model assessment of insulin resistance (HOMA-IR), and homeostasis model assessment of b-cell function (HOMA-b) were also evaluated. Baseline characteristics were similar between the 2 groups. Compared with placebo, linagliptin therapy resulted in a significant decrease in HbA1C (–1.2±0.7% vs. –0.4±0.4%, P
