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Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia).
Diabetes Metab Res Rev. 2014 Nov; 30(8):726-35.DM

Abstract

BACKGROUND

This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.

METHODS

In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA1c) from baseline to week 24.

RESULTS

A total of 391 patients were randomized. Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: -0.36%, p = 0.0004). A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo. Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: -4.28 mmol/L, p < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109). There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (lixisenatide: -1.50 kg, placebo: -1.24 kg; p = 0.296). The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively. The most common TEAE in the lixisenatide group was nausea (16.3% vs 2.6% with placebo). The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported.

CONCLUSIONS

In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study.

Authors+Show Affiliations

Chinese People's Liberation Army General Hospital, Beijing, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24639432

Citation

Yu Pan, Chang, et al. "Lixisenatide Treatment Improves Glycaemic Control in Asian Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin With or Without Sulfonylurea: a Randomized, Double-blind, Placebo-controlled, 24-week Trial (GetGoal-M-Asia)." Diabetes/metabolism Research and Reviews, vol. 30, no. 8, 2014, pp. 726-35.
Yu Pan C, Han P, Liu X, et al. Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). Diabetes Metab Res Rev. 2014;30(8):726-35.
Yu Pan, C., Han, P., Liu, X., Yan, S., Feng, P., Zhou, Z., Lv, X., Tian, H., Jin Kui, Y., Su, B., Shang, S., & Niemoeller, E. (2014). Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). Diabetes/metabolism Research and Reviews, 30(8), 726-35. https://doi.org/10.1002/dmrr.2541
Yu Pan C, et al. Lixisenatide Treatment Improves Glycaemic Control in Asian Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin With or Without Sulfonylurea: a Randomized, Double-blind, Placebo-controlled, 24-week Trial (GetGoal-M-Asia). Diabetes Metab Res Rev. 2014;30(8):726-35. PubMed PMID: 24639432.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). AU - Yu Pan,Chang, AU - Han,Ping, AU - Liu,Xiaoming, AU - Yan,Shengli, AU - Feng,Ping, AU - Zhou,Zhiguang, AU - Lv,Xiaofeng, AU - Tian,Hui, AU - Jin Kui,Yang, AU - Su,Benli, AU - Shang,Shuhua, AU - Niemoeller,Elisabeth, PY - 2013/09/03/received PY - 2014/02/05/revised PY - 2014/02/17/accepted PY - 2014/3/19/entrez PY - 2014/3/19/pubmed PY - 2015/7/15/medline KW - Asia KW - glucagon-like peptide-1 (GLP-1) receptor agonists KW - lixisenatide KW - type 2 diabetes mellitus (T2DM) SP - 726 EP - 35 JF - Diabetes/metabolism research and reviews JO - Diabetes Metab. Res. Rev. VL - 30 IS - 8 N2 - BACKGROUND: This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea. METHODS: In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA1c) from baseline to week 24. RESULTS: A total of 391 patients were randomized. Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: -0.36%, p = 0.0004). A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo. Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: -4.28 mmol/L, p < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109). There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (lixisenatide: -1.50 kg, placebo: -1.24 kg; p = 0.296). The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively. The most common TEAE in the lixisenatide group was nausea (16.3% vs 2.6% with placebo). The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported. CONCLUSIONS: In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study. SN - 1520-7560 UR - https://www.unboundmedicine.com/medline/citation/24639432/Lixisenatide_treatment_improves_glycaemic_control_in_Asian_patients_with_type_2_diabetes_mellitus_inadequately_controlled_on_metformin_with_or_without_sulfonylurea:_a_randomized_double_blind_placebo_controlled_24_week_trial__GetGoal_M_Asia__ L2 - https://doi.org/10.1002/dmrr.2541 DB - PRIME DP - Unbound Medicine ER -