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Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: An Individual Patient Data Meta-Analysis.
Diabetes Ther. 2016 Dec; 7(4):777-792.DT

Abstract

INTRODUCTION

Lixisenatide is a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus (T2DM). Its efficacy and safety have been assessed in a series of phase 3 studies included in the GetGoal program. In these studies, lixisenatide was found to be superior to placebo in glycemic control. The aim of this meta-analysis was to assess the safety and efficacy of lixisenatide as an adjunct therapy in Asian patients with T2DM in adequately controlled with oral antidiabetic drugs (OADs).

METHODS

We performed a meta-analysis from five lixisenatide phase 3 studies. In each of these multiethnic studies, patients with T2DM inadequately controlled (glycated hemoglobin, HbA1c ≥7%) with established OADs were randomized to lixisenatide or placebo for 24 weeks, with a balanced distribution of Asian patients in these two arms (503 and 338 patients in the intent-to-treat population, respectively).

RESULTS

Lixisenatide was superior to placebo in reducing HbA1c (weighted, total mean difference -0.57%; P = 0.002). More patients treated with lixisenatide versus placebo achieved HbA1c targets of ≤7% (49.1% vs. 28.4%, P = 0.003). Lixisenatide was superior to placebo in lowering 2-h postprandial glucose (PPG) (weighted, total mean difference -5.50 mmol/l, P = 0.0005). More patients treated with lixisenatide versus placebo achieved 2-h PPG targets of ≤7.8 mmol/l (39.2% vs. 2.2%, P < 0.0001). More patients treated with lixisenatide versus placebo achieved both an HbA1c target of ≤7% and a 2-h PPG target of ≤10 mmol/l (34.8% vs. 2.69%, P < 0.00001). The body weight of the lixisenatide group tended to decrease. Lixisenatide was generally well tolerated.

CONCLUSION

Lixisenatide as an adjunct therapy can significantly improve the glycemic control of Asian patients with type 2 DM who do not meet targets for glycemic control with an established OAD regimen.

FUNDING

Sanofi (China) Investment Co., Ltd., Shanghai, China.

Authors+Show Affiliations

Department of Endocrinology, Chinese PLA General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, China.Sanofi (China) Investment Co., Ltd., 19F Tower III Kerry Center, 1228 Middle Yan'an Road, Shanghai, China.Sanofi (China) Investment Co., Ltd., 19F Tower III Kerry Center, 1228 Middle Yan'an Road, Shanghai, China.Department of Endocrinology, Chinese PLA General Hospital, No. 28 Fuxing Road, Haidian District, Beijing, China. 13911682036@126.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27796905

Citation

Shu, Hua, et al. "Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: an Individual Patient Data Meta-Analysis." Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders, vol. 7, no. 4, 2016, pp. 777-792.
Shu H, Gu LN, Men LC, et al. Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: An Individual Patient Data Meta-Analysis. Diabetes therapy : research, treatment and education of diabetes and related disorders. 2016;7(4):777-792.
Shu, H., Gu, L. N., Men, L. C., & Lu, J. M. (2016). Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: An Individual Patient Data Meta-Analysis. Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders, 7(4), 777-792.
Shu H, et al. Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: an Individual Patient Data Meta-Analysis. Diabetes therapy : research, treatment and education of diabetes and related disorders. 2016;7(4):777-792. PubMed PMID: 27796905.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lixisenatide Improves Glycemic Control in Asian Type 2 Diabetic Patients Inadequately Controlled With Oral Antidiabetic Drugs: An Individual Patient Data Meta-Analysis. AU - Shu,Hua, AU - Gu,Li-Na, AU - Men,Li-Chuang, AU - Lu,Ju-Ming, Y1 - 2016/10/31/ PY - 2016/09/08/received PY - 2016/11/1/pubmed PY - 2016/11/1/medline PY - 2016/11/1/entrez KW - Asia KW - GLP-1 receptor agonist KW - Glycemic control KW - Lixisenatide KW - Postprandial glucose KW - Type 2 diabetes mellitus SP - 777 EP - 792 JF - Diabetes therapy : research, treatment and education of diabetes and related disorders VL - 7 IS - 4 N2 - INTRODUCTION: Lixisenatide is a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus (T2DM). Its efficacy and safety have been assessed in a series of phase 3 studies included in the GetGoal program. In these studies, lixisenatide was found to be superior to placebo in glycemic control. The aim of this meta-analysis was to assess the safety and efficacy of lixisenatide as an adjunct therapy in Asian patients with T2DM in adequately controlled with oral antidiabetic drugs (OADs). METHODS: We performed a meta-analysis from five lixisenatide phase 3 studies. In each of these multiethnic studies, patients with T2DM inadequately controlled (glycated hemoglobin, HbA1c ≥7%) with established OADs were randomized to lixisenatide or placebo for 24 weeks, with a balanced distribution of Asian patients in these two arms (503 and 338 patients in the intent-to-treat population, respectively). RESULTS: Lixisenatide was superior to placebo in reducing HbA1c (weighted, total mean difference -0.57%; P = 0.002). More patients treated with lixisenatide versus placebo achieved HbA1c targets of ≤7% (49.1% vs. 28.4%, P = 0.003). Lixisenatide was superior to placebo in lowering 2-h postprandial glucose (PPG) (weighted, total mean difference -5.50 mmol/l, P = 0.0005). More patients treated with lixisenatide versus placebo achieved 2-h PPG targets of ≤7.8 mmol/l (39.2% vs. 2.2%, P < 0.0001). More patients treated with lixisenatide versus placebo achieved both an HbA1c target of ≤7% and a 2-h PPG target of ≤10 mmol/l (34.8% vs. 2.69%, P < 0.00001). The body weight of the lixisenatide group tended to decrease. Lixisenatide was generally well tolerated. CONCLUSION: Lixisenatide as an adjunct therapy can significantly improve the glycemic control of Asian patients with type 2 DM who do not meet targets for glycemic control with an established OAD regimen. FUNDING: Sanofi (China) Investment Co., Ltd., Shanghai, China. SN - 1869-6953 UR - https://www.unboundmedicine.com/medline/citation/27796905/Lixisenatide_Improves_Glycemic_Control_in_Asian_Type_2_Diabetic_Patients_Inadequately_Controlled_With_Oral_Antidiabetic_Drugs:_An_Individual_Patient_Data_Meta_Analysis_ L2 - https://dx.doi.org/10.1007/s13300-016-0207-6 DB - PRIME DP - Unbound Medicine ER -
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