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J Diabetes Complications. 2014 Jan-Feb;28(1):40-4. doi: 10.1016/j.jdiacomp.2013.10.003. Epub 2013 Oct 14.

Once-daily prandial lixisenatide versus once-daily rapid-acting insulin in patients with type 2 diabetes mellitus insufficiently controlled with basal insulin: analysis of data from five randomized, controlled trials.

Author information

1
University Hospital Sainte Marguerite, Marseille, France. Electronic address: denis.raccah@ap-hm.fr.
2
Outcomes Research, Novosys Health, Flemington, NJ, USA.
3
Diabetes-Metabolism Franchise, Sanofi-Aventis US, Bridgewater, NJ, USA.
4
Diabetes-Metabolism Franchise, Sanofi, Paris, France.
5
University of Verona Medical School and Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy.
6
Dr Negrin Hospital, Las Palmas University, Las Palmas, Spain.
7
Department of Diabetology, Endocrinology and Nutrition, Assistance Publique Hôpitaux de Paris, Bichat Hospital, Paris, France; INSERM, Research Unit 872, Paris, France; University Paris Diderot, Sorbonne Paris Cité, UFR de Médecine, Paris, France.
8
Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.

Abstract

AIMS:

To compare the efficacy and safety of lixisenatide (LIXI), a once-daily prandial glucagon-like peptide-1 (GLP-1) receptor agonist, as add-on to basal insulin (Basal+LIXI) versus once-daily rapid-acting insulin (Basal+RAI) in patients with type 2 diabetes mellitus (T2DM).

METHODS:

Data were extracted from five randomized controlled trials assessing the efficacy and safety of basal insulin+insulin glulisine (n=3) or basal insulin+LIXI (n=2). Patients in the Basal+LIXI cohort were matched to patients in the Basal+RAI cohort using propensity score matching.

RESULTS:

In the matched population, Basal+LIXI was twice as likely to reach composite outcomes of glycated haemoglobin (HbA1c) <7% and no symptomatic hypoglycaemia compared with the Basal+RAI group (odds ratio [OR]: 1.90; 95% confidence interval [CI]: 1.01, 3.55; P=0.0455), as well as HbA1c <7% and no severe hypoglycaemia (OR: 1.97; 95 CI: 1.06, 3.66; P=0.0311). Furthermore, Basal+LIXI was more than twice as likely to reach HbA1c <7%, no weight gain and no symptomatic hypoglycaemia (OR: 2.58; 95% CI: 1.23, 5.40; P=0.0119).

CONCLUSIONS:

Both basal+LIXI and Basal+RAI improved glycaemic control in patients with T2DM with inadequate glycaemic control on basal insulin. Basal+LIXI offers an effective therapeutic option to advance basal insulin therapy, improving glucose control without weight gain and with less risk of hypoglycaemia than prandial insulin.

KEYWORDS:

Basal insulin; Basal+RAI; GLP-1 receptor agonist; Lixisenatide

PMID:
24246441
DOI:
10.1016/j.jdiacomp.2013.10.003
[Indexed for MEDLINE]

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