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Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin±Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study.
Horm Metab Res. 2015 Nov; 47(12):895-900.HM

Abstract

The aim of the study was to evaluate the efficacy and safety of once-daily lixisenatide 20 μg as add-on to basal insulin with or without sulfonylurea in Asian patients with type 2 diabetes mellitus. The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo. The primary endpoint was change from baseline in HbA1c evaluated using analysis of covariance. Once-daily lixisenatide significantly reduced mean HbA1c [least squares mean difference vs. placebo - 1.1% (- 12 mmol/mol); p<0.0001]. Significantly more patients in the lixisenatide group reached HbA1c targets of < 7% (53 mmol/mol; 31.4 vs. 2.3% for placebo; p<0.0001) and ≤ 6.5% (48 mmol/mol; 12.9 vs. 1.2% for placebo; p=0.0028). Lixisenatide significantly reduced 2-h postprandial plasma glucose (least squares mean difference vs. placebo-8.64 mmol/l; p<0.0001), glucose excursion (least squares mean difference vs. placebo - 7.80 mmol/l; p<0.0001) and fasting plasma glucose (least squares mean difference vs. placebo - 0.96 mmol/l; p=0.0126). Body weight was reduced with lixisenatide but with no significant difference vs. placebo. Gastrointestinal adverse events were more frequent with lixisenatide (61.1 vs. 11.5% for placebo) but were generally transient and mild-to-moderate in intensity. The incidence of symptomatic hypoglycemia was 39.0 vs. 13.5% in patients receiving sulfonylureas and 32.3 vs. 22.9% in those not receiving sulfonylureas, for lixisenatide and placebo, respectively. In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide was well tolerated and led to significant and clinically relevant improvement in glycemic control, with a pronounced effect on postprandial plasma glucose.

Authors+Show Affiliations

Diabetes, Clinical Nutrition and Endocrinology, Kansai Electric Power Hospital, Osaka, Japan.Sanofi, Tokyo, Japan.Sanofi, Frankfurt, Germany.Sanofi, Tokyo, Japan.Sanofi, Tokyo, Japan.Diabetes, Clinical Nutrition and Endocrinology, Kansai Electric Power Hospital, Osaka, Japan.Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Pub Type(s)

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

Language

eng

PubMed ID

26039935

Citation

Seino, Y, et al. "Efficacy and Safety of Lixisenatide in Japanese Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin±Sulfonylurea: a Subanalysis of the GetGoal-L-Asia Study." Hormone and Metabolic Research = Hormon- Und Stoffwechselforschung = Hormones Et Metabolisme, vol. 47, no. 12, 2015, pp. 895-900.
Seino Y, Ikeda Y, Niemoeller E, et al. Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin±Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study. Horm Metab Res. 2015;47(12):895-900.
Seino, Y., Ikeda, Y., Niemoeller, E., Watanabe, D., Takagi, H., Yabe, D., & Inagaki, N. (2015). Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin±Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study. Hormone and Metabolic Research = Hormon- Und Stoffwechselforschung = Hormones Et Metabolisme, 47(12), 895-900. https://doi.org/10.1055/s-0035-1549875
Seino Y, et al. Efficacy and Safety of Lixisenatide in Japanese Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin±Sulfonylurea: a Subanalysis of the GetGoal-L-Asia Study. Horm Metab Res. 2015;47(12):895-900. PubMed PMID: 26039935.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Lixisenatide in Japanese Patients with Type 2 Diabetes Insufficiently Controlled with Basal Insulin±Sulfonylurea: A Subanalysis of the GetGoal-L-Asia Study. AU - Seino,Y, AU - Ikeda,Y, AU - Niemoeller,E, AU - Watanabe,D, AU - Takagi,H, AU - Yabe,D, AU - Inagaki,N, Y1 - 2015/06/03/ PY - 2015/6/4/entrez PY - 2015/6/4/pubmed PY - 2016/9/16/medline SP - 895 EP - 900 JF - Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme JO - Horm. Metab. Res. VL - 47 IS - 12 N2 - The aim of the study was to evaluate the efficacy and safety of once-daily lixisenatide 20 μg as add-on to basal insulin with or without sulfonylurea in Asian patients with type 2 diabetes mellitus. The study as a subanalysis of the 159 Japanese patients from the 24-week double-blind GetGoal-L-Asia study (NCT00866658) who received once-daily lixisenatide or placebo. The primary endpoint was change from baseline in HbA1c evaluated using analysis of covariance. Once-daily lixisenatide significantly reduced mean HbA1c [least squares mean difference vs. placebo - 1.1% (- 12 mmol/mol); p<0.0001]. Significantly more patients in the lixisenatide group reached HbA1c targets of < 7% (53 mmol/mol; 31.4 vs. 2.3% for placebo; p<0.0001) and ≤ 6.5% (48 mmol/mol; 12.9 vs. 1.2% for placebo; p=0.0028). Lixisenatide significantly reduced 2-h postprandial plasma glucose (least squares mean difference vs. placebo-8.64 mmol/l; p<0.0001), glucose excursion (least squares mean difference vs. placebo - 7.80 mmol/l; p<0.0001) and fasting plasma glucose (least squares mean difference vs. placebo - 0.96 mmol/l; p=0.0126). Body weight was reduced with lixisenatide but with no significant difference vs. placebo. Gastrointestinal adverse events were more frequent with lixisenatide (61.1 vs. 11.5% for placebo) but were generally transient and mild-to-moderate in intensity. The incidence of symptomatic hypoglycemia was 39.0 vs. 13.5% in patients receiving sulfonylureas and 32.3 vs. 22.9% in those not receiving sulfonylureas, for lixisenatide and placebo, respectively. In Japanese patients with type 2 diabetes mellitus, once-daily lixisenatide was well tolerated and led to significant and clinically relevant improvement in glycemic control, with a pronounced effect on postprandial plasma glucose. SN - 1439-4286 UR - https://www.unboundmedicine.com/medline/citation/26039935/Efficacy_and_Safety_of_Lixisenatide_in_Japanese_Patients_with_Type_2_Diabetes_Insufficiently_Controlled_with_Basal_Insulin±Sulfonylurea:_A_Subanalysis_of_the_GetGoal_L_Asia_Study_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0035-1549875 DB - PRIME DP - Unbound Medicine ER -