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Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia).
Diabetes Obes Metab. 2012 Oct; 14(10):910-7.DO

Abstract

AIMS

To assess the efficacy and safety of once-daily lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea.

METHODS

In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily. The primary endpoint was HbA(1c) change from baseline to week 24.

RESULTS

Once-daily lixisenatide significantly improved HbA(1c) versus placebo (LS mean difference vs. placebo = -0.88% [95%CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA(1c) <7.0% (35.6 vs. 5.2%) and ≤ 6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on lixisenatide completed the study versus 92% on placebo. Ten (6.5%) lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported.

CONCLUSIONS

In an Asian type 2 diabetes population insufficiently controlled by basal insulin ± sulfonylurea, once-daily lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated.

Authors+Show Affiliations

Kansai Electric Power Hospital, Osaka, Japan. seino.yutaka@e2.kepco.co.jpNo 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

22564709

Citation

Seino, Y, et al. "Randomized, Double-blind, Placebo-controlled Trial of the Once-daily GLP-1 Receptor Agonist Lixisenatide in Asian Patients With Type 2 Diabetes Insufficiently Controlled On Basal Insulin With or Without a Sulfonylurea (GetGoal-L-Asia)." Diabetes, Obesity & Metabolism, vol. 14, no. 10, 2012, pp. 910-7.
Seino Y, Min KW, Niemoeller E, et al. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14(10):910-7.
Seino, Y., Min, K. W., Niemoeller, E., & Takami, A. (2012). Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes, Obesity & Metabolism, 14(10), 910-7. https://doi.org/10.1111/j.1463-1326.2012.01618.x
Seino Y, et al. Randomized, Double-blind, Placebo-controlled Trial of the Once-daily GLP-1 Receptor Agonist Lixisenatide in Asian Patients With Type 2 Diabetes Insufficiently Controlled On Basal Insulin With or Without a Sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14(10):910-7. PubMed PMID: 22564709.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). AU - Seino,Y, AU - Min,K W, AU - Niemoeller,E, AU - Takami,A, AU - ,, Y1 - 2012/05/30/ PY - 2012/02/10/received PY - 2012/03/14/revised PY - 2012/05/02/accepted PY - 2012/5/9/entrez PY - 2012/5/9/pubmed PY - 2013/4/20/medline SP - 910 EP - 7 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 14 IS - 10 N2 - AIMS: To assess the efficacy and safety of once-daily lixisenatide versus placebo in Asian patients with type 2 diabetes insufficiently controlled on basal insulin ± sulfonylurea. METHODS: In this 24-week, randomized, double-blind, placebo-controlled, parallel-group, multicentre study, participants (mean baseline HbA(1c) 8.53%) from Japan, Republic of Korea, Taiwan and the Philippines received lixisenatide (n = 154) or placebo (n = 157) in a stepwise dose increase to 20 µg once daily. The primary endpoint was HbA(1c) change from baseline to week 24. RESULTS: Once-daily lixisenatide significantly improved HbA(1c) versus placebo (LS mean difference vs. placebo = -0.88% [95%CI= -1.116, -0.650]; p < 0.0001), and allowed more patients to achieve HbA(1c) <7.0% (35.6 vs. 5.2%) and ≤ 6.5% (17.8 vs. 1.3%). Lixisenatide also significantly improved 2-h postprandial plasma glucose and glucose excursion, average 7-point self-monitored blood glucose and fasting plasma glucose. Lixisenatide was well tolerated; 86% of patients on lixisenatide completed the study versus 92% on placebo. Ten (6.5%) lixisenatide and 9 (5.7%) placebo patients experienced serious adverse events. More lixisenatide patients [14 (9.1%)] discontinued for adverse events versus placebo [5 (3.2%)], mainly with gastrointestinal causes. Nausea and vomiting were reported in 39.6 and 18.2% of patients on lixisenatide versus 4.5 and 1.9% on placebo. Symptomatic hypoglycaemia was more frequent with lixisenatide (42.9%) versus placebo (23.6%), but was similar between groups (32.6 vs. 28.3%, respectively), in those not receiving sulfonylureas. No severe hypoglycaemia was reported. CONCLUSIONS: In an Asian type 2 diabetes population insufficiently controlled by basal insulin ± sulfonylurea, once-daily lixisenatide significantly improved glycaemic control, with a pronounced postprandial effect, and was well tolerated. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/22564709/Randomized_double_blind_placebo_controlled_trial_of_the_once_daily_GLP_1_receptor_agonist_lixisenatide_in_Asian_patients_with_type_2_diabetes_insufficiently_controlled_on_basal_insulin_with_or_without_a_sulfonylurea__GetGoal_L_Asia__ L2 - https://doi.org/10.1111/j.1463-1326.2012.01618.x DB - PRIME DP - Unbound Medicine ER -