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Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S).
J Diabetes Complications. 2014 May-Jun; 28(3):386-92.JD

Abstract

AIMS

To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin.

METHODS

In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin. Primary outcome was change in HbA1c from baseline to Week 24.

RESULTS

Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo (LS mean: -0.85% vs. -0.10%; p<0.0001) and more patients achieved HbA1c <7.0% (36.4% vs. 13.5%; p<0.0001). Lixisenatide significantly lowered FPG and body weight versus placebo. In breakfast meal test patients, lixisenatide reduced 2-hour PPG versus placebo (LS mean: -111.48 vs. -3.80 mg/dL [-6.19 vs. -0.21 mmol/L]; p<0.0001) and glucose excursion (-94.11 vs. +6.24 mg/dL [-5.22 vs. +0.35 mmol/L]), and reduced 2-hour glucagon, insulin, proinsulin, and C-peptide. The percentage of AEs was 68.3% for lixisenatide and 61.1% for placebo; and for SAEs: 3.5% versus 5.6%, respectively. Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs. 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide.

CONCLUSIONS

Once-daily lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks.

Authors+Show Affiliations

Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA. Electronic address: JulioRosenstock@DallasDiabetes.com.Centre for Clinical Studies, GWT-TUD GmbH, Dresden, Germany.Bangalore Diabetes Centre, Bangalore, India.Eulji General Hospital, Seoul, Republic of Korea.Sanofi R&D, Chilly-Mazarin, France.Sanofi R&D, Paris, France.Sanofi, Bridgewater, NJ, USA.Sanofi R&D, Frankfurt, Germany.Medstar Health Research Institute and Georgetown University Medical School, Washington, DC, USA.

Pub Type(s)

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

Language

eng

PubMed ID

24650952

Citation

Rosenstock, Julio, et al. "Beneficial Effects of Once-daily Lixisenatide On Overall and Postprandial Glycemic Levels Without Significant Excess of Hypoglycemia in Type 2 Diabetes Inadequately Controlled On a Sulfonylurea With or Without Metformin (GetGoal-S)." Journal of Diabetes and Its Complications, vol. 28, no. 3, 2014, pp. 386-92.
Rosenstock J, Hanefeld M, Shamanna P, et al. Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S). J Diabetes Complicat. 2014;28(3):386-92.
Rosenstock, J., Hanefeld, M., Shamanna, P., Min, K. W., Boka, G., Miossec, P., Zhou, T., Muehlen-Bartmer, I., & Ratner, R. E. (2014). Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S). Journal of Diabetes and Its Complications, 28(3), 386-92. https://doi.org/10.1016/j.jdiacomp.2014.01.012
Rosenstock J, et al. Beneficial Effects of Once-daily Lixisenatide On Overall and Postprandial Glycemic Levels Without Significant Excess of Hypoglycemia in Type 2 Diabetes Inadequately Controlled On a Sulfonylurea With or Without Metformin (GetGoal-S). J Diabetes Complicat. 2014 May-Jun;28(3):386-92. PubMed PMID: 24650952.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S). AU - Rosenstock,Julio, AU - Hanefeld,Markolf, AU - Shamanna,Paramesh, AU - Min,Kyung Wan, AU - Boka,Gabor, AU - Miossec,Patrick, AU - Zhou,Tianyue, AU - Muehlen-Bartmer,Isabel, AU - Ratner,Robert E, Y1 - 2014/01/28/ PY - 2013/10/03/received PY - 2014/01/03/revised PY - 2014/01/20/accepted PY - 2014/3/22/entrez PY - 2014/3/22/pubmed PY - 2015/2/11/medline KW - GLP-1 receptor agonists KW - Lixisenatide KW - Sulfonylurea KW - Type 2 diabetes SP - 386 EP - 92 JF - Journal of diabetes and its complications JO - J. Diabetes Complicat. VL - 28 IS - 3 N2 - AIMS: To assess efficacy and safety of lixisenatide once-daily versus placebo in type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU) ± metformin. METHODS: In this randomized, double-blind, two-arm, parallel-group, multicenter study, patients received lixisenatide 20 μg once-daily or placebo for 24 weeks in a stepwise dose increase on top of SUs ± metformin. Primary outcome was change in HbA1c from baseline to Week 24. RESULTS: Lixisenatide provided a significant reduction in HbA1c at Week 24 versus placebo (LS mean: -0.85% vs. -0.10%; p<0.0001) and more patients achieved HbA1c <7.0% (36.4% vs. 13.5%; p<0.0001). Lixisenatide significantly lowered FPG and body weight versus placebo. In breakfast meal test patients, lixisenatide reduced 2-hour PPG versus placebo (LS mean: -111.48 vs. -3.80 mg/dL [-6.19 vs. -0.21 mmol/L]; p<0.0001) and glucose excursion (-94.11 vs. +6.24 mg/dL [-5.22 vs. +0.35 mmol/L]), and reduced 2-hour glucagon, insulin, proinsulin, and C-peptide. The percentage of AEs was 68.3% for lixisenatide and 61.1% for placebo; and for SAEs: 3.5% versus 5.6%, respectively. Lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs. 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide. CONCLUSIONS: Once-daily lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks. SN - 1873-460X UR - https://www.unboundmedicine.com/medline/citation/24650952/Beneficial_effects_of_once_daily_lixisenatide_on_overall_and_postprandial_glycemic_levels_without_significant_excess_of_hypoglycemia_in_type_2_diabetes_inadequately_controlled_on_a_sulfonylurea_with_or_without_metformin__GetGoal_S__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1056-8727(14)00013-0 DB - PRIME DP - Unbound Medicine ER -