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Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono).
Diabetes Care. 2012 Jun; 35(6):1225-31.DC

Abstract

OBJECTIVE

To assess efficacy and safety of lixisenatide monotherapy in type 2 diabetes.

RESEARCH DESIGN AND METHODS

Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy (HbA(1c) 7-10%) allocated to one of four once-daily subcutaneous dose increase regimens: lixisenatide 2-step (10 μg for 1 week, 15 μg for 1 week, and then 20 μg; n = 120), lixisenatide 1-step (10 μg for 2 weeks and then 20 μg; n = 119), placebo 2-step (n = 61), or placebo 1-step (n = 61) (placebo groups were combined for analyses). Primary end point was HbA(1c) change from baseline to week 12.

RESULTS

Once-daily lixisenatide significantly improved HbA(1c) (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: -0.54% for 2-step, -0.66% for 1-step; P < 0.0001). Significantly more lixisenatide patients achieved HbA(1c) <7.0% (52.2% 2-step, 46.5% 1-step) and ≤ 6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01). Lixisenatide led to marked significant improvements of 2-h postprandial glucose levels and blood glucose excursions measured during a standardized breakfast test. A significant decrease in fasting plasma glucose was observed in both lixisenatide groups versus placebo. Mean decreases in body weight (∼2 kg) were observed in all groups. The most common adverse events were gastrointestinal-nausea was the most frequent (lixisenatide 23% overall, placebo 4.1%). Symptomatic hypoglycemia occurred in 1.7% of lixisenatide and 1.6% of placebo patients, with no severe episodes. Safety/tolerability was similar for the two dose regimens.

CONCLUSIONS

Once-daily lixisenatide monotherapy significantly improved glycemic control with a pronounced postprandial effect (75% reduction in glucose excursion) and was safe and well tolerated in type 2 diabetes.

Authors+Show Affiliations

Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana, USA. vfonseca@tulane.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22432104

Citation

Fonseca, Vivian A., et al. "Efficacy and Safety of the Once-daily GLP-1 Receptor Agonist Lixisenatide in Monotherapy: a Randomized, Double-blind, Placebo-controlled Trial in Patients With Type 2 Diabetes (GetGoal-Mono)." Diabetes Care, vol. 35, no. 6, 2012, pp. 1225-31.
Fonseca VA, Alvarado-Ruiz R, Raccah D, et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012;35(6):1225-31.
Fonseca, V. A., Alvarado-Ruiz, R., Raccah, D., Boka, G., Miossec, P., & Gerich, J. E. (2012). Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care, 35(6), 1225-31. https://doi.org/10.2337/dc11-1935
Fonseca VA, et al. Efficacy and Safety of the Once-daily GLP-1 Receptor Agonist Lixisenatide in Monotherapy: a Randomized, Double-blind, Placebo-controlled Trial in Patients With Type 2 Diabetes (GetGoal-Mono). Diabetes Care. 2012;35(6):1225-31. PubMed PMID: 22432104.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). AU - Fonseca,Vivian A, AU - Alvarado-Ruiz,Ricardo, AU - Raccah,Denis, AU - Boka,Gabor, AU - Miossec,Patrick, AU - Gerich,John E, AU - ,, Y1 - 2012/03/19/ PY - 2012/3/21/entrez PY - 2012/3/21/pubmed PY - 2012/9/19/medline SP - 1225 EP - 31 JF - Diabetes care JO - Diabetes Care VL - 35 IS - 6 N2 - OBJECTIVE: To assess efficacy and safety of lixisenatide monotherapy in type 2 diabetes. RESEARCH DESIGN AND METHODS: Randomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy (HbA(1c) 7-10%) allocated to one of four once-daily subcutaneous dose increase regimens: lixisenatide 2-step (10 μg for 1 week, 15 μg for 1 week, and then 20 μg; n = 120), lixisenatide 1-step (10 μg for 2 weeks and then 20 μg; n = 119), placebo 2-step (n = 61), or placebo 1-step (n = 61) (placebo groups were combined for analyses). Primary end point was HbA(1c) change from baseline to week 12. RESULTS: Once-daily lixisenatide significantly improved HbA(1c) (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: -0.54% for 2-step, -0.66% for 1-step; P < 0.0001). Significantly more lixisenatide patients achieved HbA(1c) <7.0% (52.2% 2-step, 46.5% 1-step) and ≤ 6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01). Lixisenatide led to marked significant improvements of 2-h postprandial glucose levels and blood glucose excursions measured during a standardized breakfast test. A significant decrease in fasting plasma glucose was observed in both lixisenatide groups versus placebo. Mean decreases in body weight (∼2 kg) were observed in all groups. The most common adverse events were gastrointestinal-nausea was the most frequent (lixisenatide 23% overall, placebo 4.1%). Symptomatic hypoglycemia occurred in 1.7% of lixisenatide and 1.6% of placebo patients, with no severe episodes. Safety/tolerability was similar for the two dose regimens. CONCLUSIONS: Once-daily lixisenatide monotherapy significantly improved glycemic control with a pronounced postprandial effect (75% reduction in glucose excursion) and was safe and well tolerated in type 2 diabetes. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/22432104/Efficacy_and_safety_of_the_once_daily_GLP_1_receptor_agonist_lixisenatide_in_monotherapy:_a_randomized_double_blind_placebo_controlled_trial_in_patients_with_type_2_diabetes__GetGoal_Mono__ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=22432104 DB - PRIME DP - Unbound Medicine ER -