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Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X).
Diabetes Care. 2013 Oct; 36(10):2945-51.DC

Abstract

OBJECTIVE

To compare efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin.

RESEARCH DESIGN AND METHODS

Adults with diabetes inadequately controlled (HbA1c 7-10%) with metformin were randomized to lixisenatide 20 μg once daily (n=318) or exenatide 10 μg twice daily (n=316) in a 24-week (main period), open-label, parallel-group, multicenter study. The primary objective was a noninferiority assessment of lixisenatide versus exenatide in HbA1c change from baseline to week 24.

RESULTS

Lixisenatide once daily demonstrated noninferiority in HbA1c reduction versus exenatide twice daily. The least squares mean change was -0.79% (mean decrease 7.97 to 7.17%) for lixisenatide versus -0.96% (mean decrease 7.96 to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 0.033-0.297), meeting a predefined noninferiority upper CI margin of 0.4%. Responder rate (HbA1c<7.0%) and improvements in fasting plasma glucose were comparable. Both agents induced weight loss (from 94.5 to 91.7 kg and from 96.7 to 92.9 kg with lixisenatide and exenatide, respectively). Incidence of adverse events (AEs) was similar for lixisenatide and exenatide, as was incidence of serious AEs (2.8 and 2.2%, respectively). Discontinuations attributable to AEs occurred in 33 lixisenatide (10.4%) and 41 exenatide (13.0%) patients. In the lixisenatide group, fewer participants experienced symptomatic hypoglycemia (2.5 vs. 7.9%; P<0.05), with fewer gastrointestinal events (especially nausea; 24.5 vs. 35.1%; P<0.05).

CONCLUSIONS

Add-on lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated noninferior improvements in HbA1c, with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily.

Authors+Show Affiliations

Corresponding author: Julio Rosenstock, juliorosenstock@dallasdiabetes.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23698396

Citation

Rosenstock, Julio, et al. "Efficacy and Safety of Lixisenatide once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled On Metformin: a 24-week, Randomized, Open-label, Active-controlled Study (GetGoal-X)." Diabetes Care, vol. 36, no. 10, 2013, pp. 2945-51.
Rosenstock J, Raccah D, Korányi L, et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care. 2013;36(10):2945-51.
Rosenstock, J., Raccah, D., Korányi, L., Maffei, L., Boka, G., Miossec, P., & Gerich, J. E. (2013). Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care, 36(10), 2945-51. https://doi.org/10.2337/dc12-2709
Rosenstock J, et al. Efficacy and Safety of Lixisenatide once Daily Versus Exenatide Twice Daily in Type 2 Diabetes Inadequately Controlled On Metformin: a 24-week, Randomized, Open-label, Active-controlled Study (GetGoal-X). Diabetes Care. 2013;36(10):2945-51. PubMed PMID: 23698396.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). AU - Rosenstock,Julio, AU - Raccah,Denis, AU - Korányi,László, AU - Maffei,Laura, AU - Boka,Gabor, AU - Miossec,Patrick, AU - Gerich,John E, Y1 - 2013/05/22/ PY - 2013/5/24/entrez PY - 2013/5/24/pubmed PY - 2014/4/24/medline SP - 2945 EP - 51 JF - Diabetes care JO - Diabetes Care VL - 36 IS - 10 N2 - OBJECTIVE: To compare efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin. RESEARCH DESIGN AND METHODS: Adults with diabetes inadequately controlled (HbA1c 7-10%) with metformin were randomized to lixisenatide 20 μg once daily (n=318) or exenatide 10 μg twice daily (n=316) in a 24-week (main period), open-label, parallel-group, multicenter study. The primary objective was a noninferiority assessment of lixisenatide versus exenatide in HbA1c change from baseline to week 24. RESULTS: Lixisenatide once daily demonstrated noninferiority in HbA1c reduction versus exenatide twice daily. The least squares mean change was -0.79% (mean decrease 7.97 to 7.17%) for lixisenatide versus -0.96% (mean decrease 7.96 to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 0.033-0.297), meeting a predefined noninferiority upper CI margin of 0.4%. Responder rate (HbA1c<7.0%) and improvements in fasting plasma glucose were comparable. Both agents induced weight loss (from 94.5 to 91.7 kg and from 96.7 to 92.9 kg with lixisenatide and exenatide, respectively). Incidence of adverse events (AEs) was similar for lixisenatide and exenatide, as was incidence of serious AEs (2.8 and 2.2%, respectively). Discontinuations attributable to AEs occurred in 33 lixisenatide (10.4%) and 41 exenatide (13.0%) patients. In the lixisenatide group, fewer participants experienced symptomatic hypoglycemia (2.5 vs. 7.9%; P<0.05), with fewer gastrointestinal events (especially nausea; 24.5 vs. 35.1%; P<0.05). CONCLUSIONS: Add-on lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated noninferior improvements in HbA1c, with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/23698396/Efficacy_and_safety_of_lixisenatide_once_daily_versus_exenatide_twice_daily_in_type_2_diabetes_inadequately_controlled_on_metformin:_a_24_week_randomized_open_label_active_controlled_study__GetGoal_X__ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=23698396 DB - PRIME DP - Unbound Medicine ER -