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Intensification of Basal Insulin Therapy with Lixisenatide in Patients with Type 2 Diabetes in a Real-World Setting: The BASAL-LIXI Study.

Authors
  • Bellido, Diego1
  • Abellán, Pablo2, 3
  • Ruiz Palomar, José Manuel4
  • Álvarez Sintes, Rogelio5
  • Nubiolae, Andreu6
  • Bellido, Virginia7
  • Romero, Gracia8
  • 1 Department of Endocrinology and Nutrition, Ferrol Universitary Hospital Complex (CHUF), Ferrol, Spain. , (Spain)
  • 2 Department of Endocrinology and Nutrition, Castellón General Universitary Hospital, Castellón de la Plana, Spain; Department of Medicine, Universidad Cardenal Herrera-CEU University, CEU Universities, Castellón, Spain. , (Spain)
  • 3 Department of Endocrinology and Nutrition, Elda Hospital, Elda, Spain. , (Spain)
  • 4 Department of Endocrinology and Nutrition, Quirón Health, Miguel Domínguez Hospitals Group, Pontevedra, Spain. , (Spain)
  • 5 Department of Endocrinology and Nutrition, Medigroup Nubiola Center, Barcelona, Spain. , (Spain)
  • 6 Department of Endocrinology and Nutrition, Cruces Universitary Hospital, Barakaldo, Spain. , (Spain)
  • 7 Medical department, Sanofi Barcelona, Barcelona, Spain. , (Spain)
  • 8 Sanofi Barcelona, Barcelona, Spain. , (Spain)
Type
Published Article
Journal
Current Therapeutic Research
Publisher
Elsevier
Publication Date
Jan 01, 2018
Volume
89
Pages
37–42
Identifiers
DOI: 10.1016/j.curtheres.2018.09.001
PMID: 30455779
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Basal insulin reduces fasting blood glucose levels, but postprandial blood glucose levels may remain higher. Traditional strategies with rapid insulin intensification can cause hypoglycemic episodes and weight gain. Glucagon-like peptide-1 receptor agonists, such as the short-acting lixisenatide, are able to control postprandial excursions, without weight gain, and with a low risk of hypoglycemic events. Due to the limited data on the combination of lixisenatide with basal insulin (with or without oral antidiabetes drugs) in clinical practice, this study evaluated changes in parameters associated with glycemic control and anthropometric data after 24 weeks of this therapy intensification. This was a multicenter, retrospective observational study of 129 patients with type 2 diabetes that was uncontrolled by basal insulin. Their treatment was intensified by the addition of lixisenatide at least 24 weeks before being included in the study. Data were retrospectively collected to determine changes in glycated hemoglobin (HbA1c) levels, blood glucose levels, weight, and body mass index. Adverse reactions and hypoglycemic events were also recorded. After 24 weeks of therapy intensification with lixisenatide, a significant reduction in HbA1c levels was observed (-1.1%; P < 0.001). An HbA1c <7% was achieved in 30.2% of patients, and 17.1% reached an HbA1c <6.5%. There was a reduction in fasting blood glucose (31.8 [60.3] mg/dL; P < 0.001) and postprandial blood glucose (55.0 [49] mg/dL; P < 0.001) levels, as well as body weight (4.0 [5.4] kg; P < 0.001) and body mass index (1.5 [1.9]; P < 0.001). The most commonly observed adverse reactions were nausea (n = 9), in line with previous studies. Hypoglycemia events were rare; only reported in 2 patients. Intensification strategy based on lixisenatide added to basal insulin (with or without oral antidiabetes drugs) can be an effective treatment option in patients with uncontrolled type 2 diabetes. In this small, selected population, glycemic control was significantly improved in terms of HbA1, fasting blood glucose levels, and postprandial glucose levels, with a reduction of body weight and low risk of hypoglycemic events. (Curr Ther Res Clin Exp. 2018; 79:XXX-XXX).

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