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Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal-S.
J Diabetes Investig. 2015 Mar; 6(2):201-9.JD

Abstract

AIMS/INTRODUCTION

This was a subanalysis of Japanese patients included in the glucagon-like peptide-1 receptor agonist AVE0010 in patients with type 2 diabetes mellitus for glycemic control and safety evaluation (GetGoal-S) study - a 24-week, randomized, placebo-controlled study of lixisenatide in patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin.

MATERIALS AND METHODS

In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo. The primary outcome was change in glycated hemoglobin.

RESULTS

At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo -1.1% [12 mmol/mol, P < 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo. Lixisenatide produced statistically significant reductions in 2-h postprandial plasma glucose (least squares mean difference vs the placebo -8.51 mmol/L, P < 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo -0.65 mmol/L, P = 0.0454). Bodyweight decreased with both lixisenatide and the placebo (least squares mean change -1.12 kg for lixisenatide, -1.02 kg for placebo). The overall incidence of adverse events was similar for lixisenatide and the placebo (84.2 and 82.4%, respectively), the most frequent being gastrointestinal disorders (52.6% for lixisenatide vs 29.4% for placebo). The incidence of symptomatic hypoglycemia was higher with lixisenatide vs the placebo (17.1 and 9.8%, respectively), with no cases of severe symptomatic hypoglycemia in either group.

CONCLUSIONS

In the Japanese subpopulation of the GetGoal-S study, lixisenatide produced a significant and clinically relevant improvement in glycated hemoglobin, with a pronounced improvement in postprandial plasma glucose, and a good safety and tolerability profile.

Authors+Show Affiliations

The Institute for Adult Disease, Asahi Life Foundation Tokyo, Japan.Sanofi R&D Frankfurt, Germany.Sanofi Tokyo, Japan.Sanofi Tokyo, Japan.Kansai Electric Power Hospital Osaka, Japan.Kansai Electric Power Hospital Osaka, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25802728

Citation

Onishi, Yukiko, et al. "Efficacy and Safety of Lixisenatide in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled By Sulfonylurea With or Without Metformin: Subanalysis of GetGoal-S." Journal of Diabetes Investigation, vol. 6, no. 2, 2015, pp. 201-9.
Onishi Y, Niemoeller E, Ikeda Y, et al. Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal-S. J Diabetes Investig. 2015;6(2):201-9.
Onishi, Y., Niemoeller, E., Ikeda, Y., Takagi, H., Yabe, D., & Seino, Y. (2015). Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal-S. Journal of Diabetes Investigation, 6(2), 201-9. https://doi.org/10.1111/jdi.12275
Onishi Y, et al. Efficacy and Safety of Lixisenatide in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled By Sulfonylurea With or Without Metformin: Subanalysis of GetGoal-S. J Diabetes Investig. 2015;6(2):201-9. PubMed PMID: 25802728.
* 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 mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal-S. AU - Onishi,Yukiko, AU - Niemoeller,Elisabeth, AU - Ikeda,Yukio, AU - Takagi,Hiroki, AU - Yabe,Daisuke, AU - Seino,Yutaka, Y1 - 2014/09/24/ PY - 2014/04/07/received PY - 2014/07/10/revised PY - 2014/08/07/accepted PY - 2015/3/25/entrez PY - 2015/3/25/pubmed PY - 2015/3/25/medline KW - Glucagon-like peptide-1 receptor KW - Japanese KW - Lixisenatide SP - 201 EP - 9 JF - Journal of diabetes investigation JO - J Diabetes Investig VL - 6 IS - 2 N2 - AIMS/INTRODUCTION: This was a subanalysis of Japanese patients included in the glucagon-like peptide-1 receptor agonist AVE0010 in patients with type 2 diabetes mellitus for glycemic control and safety evaluation (GetGoal-S) study - a 24-week, randomized, placebo-controlled study of lixisenatide in patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin. MATERIALS AND METHODS: In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo. The primary outcome was change in glycated hemoglobin. RESULTS: At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo -1.1% [12 mmol/mol, P < 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo. Lixisenatide produced statistically significant reductions in 2-h postprandial plasma glucose (least squares mean difference vs the placebo -8.51 mmol/L, P < 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo -0.65 mmol/L, P = 0.0454). Bodyweight decreased with both lixisenatide and the placebo (least squares mean change -1.12 kg for lixisenatide, -1.02 kg for placebo). The overall incidence of adverse events was similar for lixisenatide and the placebo (84.2 and 82.4%, respectively), the most frequent being gastrointestinal disorders (52.6% for lixisenatide vs 29.4% for placebo). The incidence of symptomatic hypoglycemia was higher with lixisenatide vs the placebo (17.1 and 9.8%, respectively), with no cases of severe symptomatic hypoglycemia in either group. CONCLUSIONS: In the Japanese subpopulation of the GetGoal-S study, lixisenatide produced a significant and clinically relevant improvement in glycated hemoglobin, with a pronounced improvement in postprandial plasma glucose, and a good safety and tolerability profile. SN - 2040-1116 UR - https://www.unboundmedicine.com/medline/citation/25802728/Efficacy_and_safety_of_lixisenatide_in_Japanese_patients_with_type_2_diabetes_mellitus_inadequately_controlled_by_sulfonylurea_with_or_without_metformin:_Subanalysis_of_GetGoal_S_ L2 - https://doi.org/10.1111/jdi.12275 DB - PRIME DP - Unbound Medicine ER -
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