Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial
| Autor: | Richard M. Bergenstal, Jeffrey Unger, Elisabeth Niemoeller, Carol Wysham, Hailing Guo, Guillermo González-Gálvez, Elisabeth Souhami, Diego Bellido, Akane Takami, Julio Rosenstock, Vanita R. Aroda |
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| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Endocrinology Diabetes and Metabolism medicine.medical_treatment 030209 endocrinology & metabolism Type 2 diabetes 030204 cardiovascular system & hematology Hypoglycemia Gastroenterology 03 medical and health sciences Lixisenatide chemistry.chemical_compound 0302 clinical medicine Internal medicine Diabetes mellitus Internal Medicine medicine Advanced and Specialized Nursing business.industry Insulin glargine Insulin medicine.disease Metformin Endocrinology Basal (medicine) chemistry business medicine.drug |
| Zdroj: | Diabetes Care. 39:1972-1980 |
| ISSN: | 1935-5548 0149-5992 |
| DOI: | 10.2337/dc16-1495 |
| Popis: | OBJECTIVE This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents. RESEARCH DESIGN AND METHODS After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m2) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose RESULTS HbA1c decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA1c from baseline compared with iGlar (–1.1% vs. –0.6%, P < 0.0001), reaching a mean final HbA1c of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA1c CONCLUSIONS Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes. |
| Databáze: | OpenAIRE |
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